Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery
Primary Purpose
Hypotension,Controlled
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension,Controlled focused on measuring controlled hypotension, cardiac output on, blood loss, surgical field, oxygen supply, oxygen consumption
Eligibility Criteria
Inclusion Criteria:
- Aged between 35 and 70 years
- Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body)
Exclusion Criteria:
History of cardiovascular function
- congestive heart failure [CHF]
- coronary artery disease [CAD]
- cerebrovascular insuffiency)
- poorly controlled arterial hypertension
- pre-existing coagulation defects
- Patients taking anticoagulatory medication including aspirin
- Patients taking corticosteroid therapy
Sites / Locations
- Guangzhou Red cross hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hypotension group (group H )
control group (group C )
Arm Description
particcipants in hypotension group are received controlled hypertension in the operation.
participants in cotrol group are received no controlled hypertension in the operation
Outcomes
Primary Outcome Measures
cardiac index(CI) after the participants are taken into the operating room
CI(L/min/m^2)
cardiac index(CI) after the induction
cardiac index (CI,L/min/m^2)
cardiac index(CI) at 5 minutes after tubation
cardiac index (CI,L/min/m^2)
cardiac index(CI) at 10 minutes after tubation
cardiac index (CI,L/min/m^2).
cardiac index(CI) at 15 minutes after tubation
cardiac index (CI,L/min/m^2)
cardiac index(CI) at 30 minutes after tubation
cardiac index (CI,L/min/m^2)
cardiac index(CI) at 45 minutes after tubation
cardiac index (CI,L/min/m^2)
cardiac index(CI) at the end of surgery
cardiac index (CI,L/min/m^2).
cardiac index(CI) at 1 minute after extubation
cardiac index (CI,L/min/m^2)
cardiac index(CI) at 5 minutes after extubation
cardiac index (CI,L/min/m^2)
Secondary Outcome Measures
Partial pressure of oxygen after the participants are taken into the operating room
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation after the participants are taken into the operating room
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin after the participants are taken into the operating room
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate after the participants are taken into the operating room
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen after the participants are taken into the operating room
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation after the participants are taken into the operating room
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index after the participants are taken into the operating room
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index after the participants are taken into the operating room
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen after the induction
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation after the induction
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin after the induction
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate after the induction
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen after the induction
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation after the induction
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index after the induction
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index after the induction
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 5 minutes after tubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 5 minutes after tubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 5 minutes after tubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 5 minutes after tubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 5 minutes after tubation
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at 5 minutes after tubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 5 minutes after tubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 5 minutes after tubation
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 10 minutes after tubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 10 minutes after tubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 10 minutes after tubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 10 minutes after tubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 10 minutes after tubation
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at 10 minutes after tubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 10 minutes after tubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 10 minutes after tubation
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 15 minutes after tubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 15 minutes after tubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 15 minutes after tubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 15 minutes after tubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 15 minutes after tubation
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at 15 minutes after tubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 15 minutes after tubation
Oxygen supply index (DO2I,ml/min/m^2)
Calculated index at 15 minutes after tubation
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 30 minutes after tubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 30 minutes after tubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 30 minutes after tubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 30 minutes after tubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 30 minutes after tubation
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at 30 minutes after tubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 30 minutes after tubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 30 minutes after tubation
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 45 minutes after tubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 45 minutes after tubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 45 minutes after tubation
Arterial blood hemoglobin (Hb,g/L)
Partial pressure central venous oxygen at 45 minutes after tubation
Partial pressure central venous oxygen(PvO2,mmHg)
Arterial blood lactate at 45 minutes after tubation
Arterial blood lactate (Lac,mmol/L)
Oxygen supply index at 45 minutes after tubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 45 minutes after tubation
Oxygen consumption index (VO2I,ml/min/m^2)
Central venous blood oxygen saturation at 45 minutes after tubation
Central venous blood oxygen saturation(ScvO2,%)
Partial pressure of oxygen at the end of surgery
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at the end of surgery
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at the end of surgery
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at the end of surgery
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at the end of surgery
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at the end of surgery
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at the end of surgery
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at the end of surgery
Oxygen consumption index (VO2I,ml/min/m^2)
Partial pressure of oxygen at 1 minute after extubation
Partial pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 1 minute after extubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 1 minute after extubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 1 minute after extubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 1 minute after extubation
Partial pressure central venous oxygen(PvO2,mmHg)
Central venous blood oxygen saturation at 1 minute after extubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 1 minute after extubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 1 minute after extubation
Oxygen consumption index (VO2I,ml/min/m^2)
Plartia pressure of oxygen at 5 minutes after extubation
Plartia pressure of oxygen (PaO2,mmHg)
Arterial oxygen saturation at 5 minutes after extubation
Arterial oxygen saturation (SaO2,%)
Arterial blood hemoglobin at 5 minutes after extubation
Arterial blood hemoglobin (Hb,g/L)
Arterial blood lactate at 5 minutes after extubation
Arterial blood lactate (Lac,mmol/L)
Partial pressure central venous oxygen at 5 minutes after extubation
Partial pressure central venous oxnyge(PvO2,mmHg)
Central venous blood oxygen saturation at 5 minutes after extubation
Central venous blood oxygen saturation(ScvO2,%)
Oxygen supply index at 5 minutes after extubation
Oxygen supply index (DO2I,ml/min/m^2)
Oxygen consumption index at 5 minutes after extubation
Oxygen consumption index (VO2I,ml/min/m^2).
mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room
MAP(mmHg)
heart rate(HR) after the participants are taken into the operating room
HR(beat per minute)
central venous pressure(CVP) after the participants are taken into the operating room
CVP(mmHg)
variability of stroke volume(SVV) after the participants are taken into the operating room
SVV (%)
mean artery pressure(MAP) after the induction
MAP(mmHg)
heart rate(HR) after the induction
HR(heart rate,beat per minute)
central venous pressure(CVP) after the induction
CVP(mmHg)
variability of stroke volume(SVV) after the induction
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at 5 minutes after tubation
MAP(mmHg)m^2)
heart rate(HR) at 5 minutes after tubation
HR(heart rate,beat per minute),
central venous pressure(CVP) at 5 minutes after tubation
CVP(mmHg)
variability of stroke volume(SVV) at 5 minutes after tubation
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at 10 minutes after tubation
MAP(mmHg)
heart rate(HR) at 10 minutes after tubation
HR(heart rate,beat per minute)
central venous pressure(CVP) at 10 minutes after tubation
CVP(mmHg)
variability of stroke volume(SVV) at 10 minutes after tubation
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at 15 minutes after tubation
MAP(mmHg)
heart rate(HR) at 15 minutes after tubation
HR(heart rate,beat per minute)
central venous pressure(CVP) at 15 minutes after tubation
CVP(mmHg)
variability of stroke volume(SVV) at 15 minutes after tubation
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at 30 minutes after tubation
MAP(mmHg)
heart rate(HR) at 30 minutes after tubation
HR(heart rate,beat per minute)
central venous pressure(CVP) at 30 minutes after tubation
CVP(mmHg)
variability of stroke volume(SVV) at 30 minutes after tubation
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at 45 minutes after tubation
MAP(mmHg)
heart rate(HR) at 45 minutes after tubation
HR(heart rate,beat per minute)
central venous pressure(CVP) at 45 minutes after tubation
CVP(mmHg)
variability of stroke volume(SVV) at 45 minutes after tubation
SVV (variability of stroke volume,%)
mean artery pressure(MAP) at the end of surgery
MAP(mmHg)
central venous pressure(CVP) at the end of surgery
CVP(mmHg)
variability of stroke volume(SVV) at the end of surgery
SVV (variability of stroke volume,%)
heart rate(HR) at the end of surgery
HR(heart rate,beat per minute)
mean artery pressure(MAP) at 1 minute after extubation
MAP(mmHg)
heart rate(HR) at 1 minute after extubation
HR(heart rate,beat per minute)
variability of stroke volume(SVV) at 1 minute after extubation
SVV (variability of stroke volume,%)
central venous pressure(CVP) at 1 minute after extubation
CVP(mmHg)
mean artery pressure(MAP) at 5 minutes after extubation
MAP(mmHg)
central venous pressure(CVP) at 5 minutes after extubation
CVP(mmHg)
heart rate(HR) at 5 minutes after extubation
HR(heart rate,beat per minute)
variability of stroke volume(SVV) at 5 minutes after extubation
SVV (variability of stroke volume,%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917004
Brief Title
Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery
Official Title
Correlation Analysis of the Effects of Management Pressure Goals (Controlled Hypotension) and Control Volume Goals (Cardiac Output, Stroke Volume Variability, Central Venous Pressure) on Intraoperative Blood and Visual Field Quality
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liang Bing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators study 160 patients undergoing spinal surgery.Participants will be randomly divided into study group and control group.The study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to CI.
Detailed Description
This study will be done in Guangzhou Red Cross Hospital .The investigators study 160 patients aged from 45 to 70 years,weight from 48 to 68kg classified as American Society of Anesthesiologists (ASAs) physical status Ⅰ-Ⅱ who will be candidate for posterior decompression of vertebral canal,discectomy and internal fixation by pediclescrew(one centrum).The investigators excluded patients with cardiovascular and cerebrovascular diseases,hepatic or renal dysfunction,and patients receiving drugs that interfere with coagulation before surgery.
Patients randomly divided into study group(group H,n=120)and control group (group C,n=40).The study group according to CI(Cardiac Index) levels of intraoperative hypotension period(mean of CI at T2,T3,T4) were divided into three groups: 1st group: CI: 1.5-2.0 L /(min•m2), 2nd group: CI: 2.0-3.0 L /(min•m2), 3rd group: CI: 3.0-4.0 L /(min•m2),and which CI < 1.5 or CI > 4.0 was eliminated the experimental group, which, in control group, CI< 2.5 or CI >4.0 was eliminated the experimental group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension,Controlled
Keywords
controlled hypotension, cardiac output on, blood loss, surgical field, oxygen supply, oxygen consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypotension group (group H )
Arm Type
Experimental
Arm Description
particcipants in hypotension group are received controlled hypertension in the operation.
Arm Title
control group (group C )
Arm Type
No Intervention
Arm Description
participants in cotrol group are received no controlled hypertension in the operation
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Other Intervention Name(s)
Controlled Hypotension
Intervention Description
The starting rate of "nitroglycerin" was 0.25 μg / kg / min and the mean arterial pressure (MAP) decreased to 80% of the baseline but not less than 70%.The drug infusion rate was adjusted so that the MAP was maintained in the range to the suture, and the administration was stopped and the blood pressure was gradually returned to the pre-depressurization level.
Primary Outcome Measure Information:
Title
cardiac index(CI) after the participants are taken into the operating room
Description
CI(L/min/m^2)
Time Frame
during surgery
Title
cardiac index(CI) after the induction
Description
cardiac index (CI,L/min/m^2)
Time Frame
during surgery
Title
cardiac index(CI) at 5 minutes after tubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
5 minutes after tubation
Title
cardiac index(CI) at 10 minutes after tubation
Description
cardiac index (CI,L/min/m^2).
Time Frame
10 minutes after tubation
Title
cardiac index(CI) at 15 minutes after tubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
15 minutes after tubation
Title
cardiac index(CI) at 30 minutes after tubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
30 minutes after tubation
Title
cardiac index(CI) at 45 minutes after tubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
45 minutes after tubation
Title
cardiac index(CI) at the end of surgery
Description
cardiac index (CI,L/min/m^2).
Time Frame
at the end of surgery
Title
cardiac index(CI) at 1 minute after extubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
1 minute after extubation
Title
cardiac index(CI) at 5 minutes after extubation
Description
cardiac index (CI,L/min/m^2)
Time Frame
5 minutes after extubation
Secondary Outcome Measure Information:
Title
Partial pressure of oxygen after the participants are taken into the operating room
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
during surgery
Title
Arterial oxygen saturation after the participants are taken into the operating room
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
during surgery
Title
Arterial blood hemoglobin after the participants are taken into the operating room
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
during surgery
Title
Arterial blood lactate after the participants are taken into the operating room
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
during surgery
Title
Partial pressure central venous oxygen after the participants are taken into the operating room
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
during surgery
Title
Central venous blood oxygen saturation after the participants are taken into the operating room
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
during surgery
Title
Oxygen supply index after the participants are taken into the operating room
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
during surgery
Title
Oxygen consumption index after the participants are taken into the operating room
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
during surgery
Title
Partial pressure of oxygen after the induction
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
during surgery
Title
Arterial oxygen saturation after the induction
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
during surgery
Title
Arterial blood hemoglobin after the induction
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
during surgery
Title
Arterial blood lactate after the induction
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
during surgery
Title
Partial pressure central venous oxygen after the induction
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
during surgery
Title
Central venous blood oxygen saturation after the induction
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
during surgery
Title
Oxygen supply index after the induction
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
during surgery
Title
Oxygen consumption index after the induction
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
during surgery
Title
Partial pressure of oxygen at 5 minutes after tubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
5 minutes after tubation
Title
Arterial oxygen saturation at 5 minutes after tubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
5 minutes after tubation
Title
Arterial blood hemoglobin at 5 minutes after tubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
5 minutes after tubation
Title
Arterial blood lactate at 5 minutes after tubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
5 minutes after tubation
Title
Partial pressure central venous oxygen at 5 minutes after tubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
5 minutes after tubation
Title
Central venous blood oxygen saturation at 5 minutes after tubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
5 minutes after tubation
Title
Oxygen supply index at 5 minutes after tubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
5 minutes after tubation
Title
Oxygen consumption index at 5 minutes after tubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
5 minutes after tubation
Title
Partial pressure of oxygen at 10 minutes after tubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
10 minutes after tubation
Title
Arterial oxygen saturation at 10 minutes after tubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
10 minutes after tubation
Title
Arterial blood hemoglobin at 10 minutes after tubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
10 minutes after tubation
Title
Arterial blood lactate at 10 minutes after tubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
10 minutes after tubation
Title
Partial pressure central venous oxygen at 10 minutes after tubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
10 minutes after tubation
Title
Central venous blood oxygen saturation at 10 minutes after tubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
10 minutes after tubation
Title
Oxygen supply index at 10 minutes after tubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
10 minutes after tubation
Title
Oxygen consumption index at 10 minutes after tubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
10 minutes after tubation
Title
Partial pressure of oxygen at 15 minutes after tubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
15 minutes after tubation
Title
Arterial oxygen saturation at 15 minutes after tubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
15 minutes after tubation
Title
Arterial blood hemoglobin at 15 minutes after tubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
15 minutes after tubation
Title
Arterial blood lactate at 15 minutes after tubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
15 minutes after tubation
Title
Partial pressure central venous oxygen at 15 minutes after tubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
15 minutes after tubation
Title
Central venous blood oxygen saturation at 15 minutes after tubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
15 minutes after tubation
Title
Oxygen supply index at 15 minutes after tubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
15 minutes after tubation
Title
Calculated index at 15 minutes after tubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
15 minutes after tubation
Title
Partial pressure of oxygen at 30 minutes after tubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
30 minutes after tubation
Title
Arterial oxygen saturation at 30 minutes after tubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
30 minutes after tubation
Title
Arterial blood hemoglobin at 30 minutes after tubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
30 minutes after tubation
Title
Arterial blood lactate at 30 minutes after tubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
30 minutes after tubation
Title
Partial pressure central venous oxygen at 30 minutes after tubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
30 minutes after tubation
Title
Central venous blood oxygen saturation at 30 minutes after tubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
30 minutes after tubation
Title
Oxygen supply index at 30 minutes after tubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
30 minutes after tubation
Title
Oxygen consumption index at 30 minutes after tubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
30 minutes after tubation
Title
Partial pressure of oxygen at 45 minutes after tubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
45 minutes after tubation
Title
Arterial oxygen saturation at 45 minutes after tubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
45 minutes after tubation
Title
Arterial blood hemoglobin at 45 minutes after tubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
45 minutes after tubation
Title
Partial pressure central venous oxygen at 45 minutes after tubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
45 minutes after tubation
Title
Arterial blood lactate at 45 minutes after tubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
45 minutes after tubation
Title
Oxygen supply index at 45 minutes after tubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
45 minutes after tubation
Title
Oxygen consumption index at 45 minutes after tubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
45 minutes after tubation
Title
Central venous blood oxygen saturation at 45 minutes after tubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
45 minutes after tubation
Title
Partial pressure of oxygen at the end of surgery
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
at the end of surgery
Title
Arterial oxygen saturation at the end of surgery
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
at the end of surgery
Title
Arterial blood hemoglobin at the end of surgery
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
at the end of surgery
Title
Arterial blood lactate at the end of surgery
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
at the end of surgery
Title
Partial pressure central venous oxygen at the end of surgery
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
at the end of surgery
Title
Central venous blood oxygen saturation at the end of surgery
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
at the end of surgery
Title
Oxygen supply index at the end of surgery
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
at the end of surgery
Title
Oxygen consumption index at the end of surgery
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
at the end of surgery
Title
Partial pressure of oxygen at 1 minute after extubation
Description
Partial pressure of oxygen (PaO2,mmHg)
Time Frame
1 minute after extubation
Title
Arterial oxygen saturation at 1 minute after extubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
1 minute after extubation
Title
Arterial blood hemoglobin at 1 minute after extubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
1 minute after extubation
Title
Arterial blood lactate at 1 minute after extubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
1 minute after extubation
Title
Partial pressure central venous oxygen at 1 minute after extubation
Description
Partial pressure central venous oxygen(PvO2,mmHg)
Time Frame
1 minute after extubation
Title
Central venous blood oxygen saturation at 1 minute after extubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
1 minute after extubation
Title
Oxygen supply index at 1 minute after extubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
1 minute after extubation
Title
Oxygen consumption index at 1 minute after extubation
Description
Oxygen consumption index (VO2I,ml/min/m^2)
Time Frame
1 minute after extubation
Title
Plartia pressure of oxygen at 5 minutes after extubation
Description
Plartia pressure of oxygen (PaO2,mmHg)
Time Frame
5 minutes after extubation
Title
Arterial oxygen saturation at 5 minutes after extubation
Description
Arterial oxygen saturation (SaO2,%)
Time Frame
5 minutes after extubation
Title
Arterial blood hemoglobin at 5 minutes after extubation
Description
Arterial blood hemoglobin (Hb,g/L)
Time Frame
5 minutes after extubation
Title
Arterial blood lactate at 5 minutes after extubation
Description
Arterial blood lactate (Lac,mmol/L)
Time Frame
5 minutes after extubation
Title
Partial pressure central venous oxygen at 5 minutes after extubation
Description
Partial pressure central venous oxnyge(PvO2,mmHg)
Time Frame
5 minutes after extubation
Title
Central venous blood oxygen saturation at 5 minutes after extubation
Description
Central venous blood oxygen saturation(ScvO2,%)
Time Frame
5 minutes after extubation
Title
Oxygen supply index at 5 minutes after extubation
Description
Oxygen supply index (DO2I,ml/min/m^2)
Time Frame
5 minutes after extubation
Title
Oxygen consumption index at 5 minutes after extubation
Description
Oxygen consumption index (VO2I,ml/min/m^2).
Time Frame
5 minutes after extubation
Title
mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room
Description
MAP(mmHg)
Time Frame
during surgery
Title
heart rate(HR) after the participants are taken into the operating room
Description
HR(beat per minute)
Time Frame
during surgery
Title
central venous pressure(CVP) after the participants are taken into the operating room
Description
CVP(mmHg)
Time Frame
during surgery
Title
variability of stroke volume(SVV) after the participants are taken into the operating room
Description
SVV (%)
Time Frame
during surgery
Title
mean artery pressure(MAP) after the induction
Description
MAP(mmHg)
Time Frame
during surgery
Title
heart rate(HR) after the induction
Description
HR(heart rate,beat per minute)
Time Frame
during surgery
Title
central venous pressure(CVP) after the induction
Description
CVP(mmHg)
Time Frame
during surgery
Title
variability of stroke volume(SVV) after the induction
Description
SVV (variability of stroke volume,%)
Time Frame
during surgery
Title
mean artery pressure(MAP) at 5 minutes after tubation
Description
MAP(mmHg)m^2)
Time Frame
5 minutes after tubation
Title
heart rate(HR) at 5 minutes after tubation
Description
HR(heart rate,beat per minute),
Time Frame
5 minutes after tubation
Title
central venous pressure(CVP) at 5 minutes after tubation
Description
CVP(mmHg)
Time Frame
5 minutes after tubation
Title
variability of stroke volume(SVV) at 5 minutes after tubation
Description
SVV (variability of stroke volume,%)
Time Frame
5 minutes after tubation
Title
mean artery pressure(MAP) at 10 minutes after tubation
Description
MAP(mmHg)
Time Frame
10 minutes after tubation
Title
heart rate(HR) at 10 minutes after tubation
Description
HR(heart rate,beat per minute)
Time Frame
10 minutes after tubation
Title
central venous pressure(CVP) at 10 minutes after tubation
Description
CVP(mmHg)
Time Frame
10 minutes after tubation
Title
variability of stroke volume(SVV) at 10 minutes after tubation
Description
SVV (variability of stroke volume,%)
Time Frame
10 minutes after tubation
Title
mean artery pressure(MAP) at 15 minutes after tubation
Description
MAP(mmHg)
Time Frame
15 minutes after tubation
Title
heart rate(HR) at 15 minutes after tubation
Description
HR(heart rate,beat per minute)
Time Frame
15 minutes after tubation
Title
central venous pressure(CVP) at 15 minutes after tubation
Description
CVP(mmHg)
Time Frame
15 minutes after tubation
Title
variability of stroke volume(SVV) at 15 minutes after tubation
Description
SVV (variability of stroke volume,%)
Time Frame
15 minutes after tubation
Title
mean artery pressure(MAP) at 30 minutes after tubation
Description
MAP(mmHg)
Time Frame
30 minutes after tubation
Title
heart rate(HR) at 30 minutes after tubation
Description
HR(heart rate,beat per minute)
Time Frame
30 minutes after tubation
Title
central venous pressure(CVP) at 30 minutes after tubation
Description
CVP(mmHg)
Time Frame
30 minutes after tubation
Title
variability of stroke volume(SVV) at 30 minutes after tubation
Description
SVV (variability of stroke volume,%)
Time Frame
30 minutes after tubation
Title
mean artery pressure(MAP) at 45 minutes after tubation
Description
MAP(mmHg)
Time Frame
45 minutes after tubation
Title
heart rate(HR) at 45 minutes after tubation
Description
HR(heart rate,beat per minute)
Time Frame
45 minutes after tubation
Title
central venous pressure(CVP) at 45 minutes after tubation
Description
CVP(mmHg)
Time Frame
45 minutes after tubation
Title
variability of stroke volume(SVV) at 45 minutes after tubation
Description
SVV (variability of stroke volume,%)
Time Frame
45 minutes after tubation
Title
mean artery pressure(MAP) at the end of surgery
Description
MAP(mmHg)
Time Frame
at the end of surgery
Title
central venous pressure(CVP) at the end of surgery
Description
CVP(mmHg)
Time Frame
at the end of surgery
Title
variability of stroke volume(SVV) at the end of surgery
Description
SVV (variability of stroke volume,%)
Time Frame
at the end of surgery
Title
heart rate(HR) at the end of surgery
Description
HR(heart rate,beat per minute)
Time Frame
at the end of surgery
Title
mean artery pressure(MAP) at 1 minute after extubation
Description
MAP(mmHg)
Time Frame
1 minute after extubation
Title
heart rate(HR) at 1 minute after extubation
Description
HR(heart rate,beat per minute)
Time Frame
1 minute after extubation
Title
variability of stroke volume(SVV) at 1 minute after extubation
Description
SVV (variability of stroke volume,%)
Time Frame
1 minute after extubation
Title
central venous pressure(CVP) at 1 minute after extubation
Description
CVP(mmHg)
Time Frame
1 minute after extubation
Title
mean artery pressure(MAP) at 5 minutes after extubation
Description
MAP(mmHg)
Time Frame
5 minutes after extubation
Title
central venous pressure(CVP) at 5 minutes after extubation
Description
CVP(mmHg)
Time Frame
5 minutes after extubation
Title
heart rate(HR) at 5 minutes after extubation
Description
HR(heart rate,beat per minute)
Time Frame
5 minutes after extubation
Title
variability of stroke volume(SVV) at 5 minutes after extubation
Description
SVV (variability of stroke volume,%)
Time Frame
5 minutes after extubation
Other Pre-specified Outcome Measures:
Title
Scores of surgical field quality after the induction
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
during surgery
Title
Scores of surgical field quality at 5 minutes after tubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
5 minutes after tubation
Title
Scores of surgical field quality at 10 minutes after tubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
10 minutes after tubation
Title
Scores of surgical field quality at 15 minutes after tubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
15 minutes after tubation
Title
Scores of surgical field quality at 30 minutes after tubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
30 minutes after tubation
Title
Scores of surgical field quality at 45 minutes after tubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
45 minutes after tubation
Title
Scores of surgical field quality at the end of surgery
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
at the end of surgery
Title
Scores of surgical field quality at 5 minutes after extubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
5 minutes after extubation
Title
Scores of surgical field quality at 1 minute after extubation
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
1 minute after extubation
Title
operation time after the induction
Description
operation time(minutes)
Time Frame
during surgery
Title
operation time after the participants are taken into the operating room
Description
operation time(minutes)
Time Frame
during surgery
Title
operation time at 5 minutes after tubation
Description
operation time(minutes)
Time Frame
5 minutes after tubation
Title
operation time at 10 minutes after tubation
Description
operation time(minutes)
Time Frame
10 minutes after tubation
Title
operation time at 15 minutes after tubation
Description
operation time(minutes)
Time Frame
15 minutes after tubation
Title
operation time at 30 minutes after tubation
Description
operation time(minutes)
Time Frame
30 minutes after tubation
Title
operation time at 45 minutes after tubation
Description
operation time(minutes)
Time Frame
45 minutes after tubation
Title
operation time at the end of surgery
Description
operation time(minutes)
Time Frame
at the end of surgery
Title
operation time at 5 minutes after extubation
Description
operation time(minutes)
Time Frame
5 minutes after extubation
Title
operation time at 1 minute after extubation
Description
operation time(mintes)
Time Frame
1 minute after extubation
Title
estimated blood loss after the induction
Description
estimated blood loss(ml)
Time Frame
during surgery
Title
estimated blood loss after the participants are taken into the operating room
Description
estimated blood loss(ml)
Time Frame
during surgery
Title
estimated blood loss at 5 minutes after tubation
Description
estimated blood loss(ml)
Time Frame
5 minutes after tubation
Title
estimated blood loss at 10 minutes after tubation
Description
estimated blood loss(ml)
Time Frame
10 minutes after tubation
Title
estimated blood loss at 15 minutes after tubation
Description
estimated blood loss(ml)
Time Frame
15 minutes after tubation
Title
estimated blood loss at 30 minutes after tubation
Description
estimated blood loss(ml)
Time Frame
30 minutes after tubation
Title
estimated blood loss at 45minutes after tubation
Description
estimated blood loss(ml)
Time Frame
45 minutes after tubation
Title
estimated blood loss at the end of surgery
Description
estimated blood loss(ml)
Time Frame
at the end of surgery
Title
estimated blood loss at 1 minute after extubation
Description
estimated blood loss(ml)
Time Frame
1 minute after extubation
Title
estimated blood loss at 5 minutes after extubation
Description
estimated blood loss(ml)
Time Frame
5 minutes after extubation
Title
Scores of surgical field quality after the participants are taken into the operating room
Description
Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged between 35 and 70 years
Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body)
Exclusion Criteria:
History of cardiovascular function
congestive heart failure [CHF]
coronary artery disease [CAD]
cerebrovascular insuffiency)
poorly controlled arterial hypertension
pre-existing coagulation defects
Patients taking anticoagulatory medication including aspirin
Patients taking corticosteroid therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cao Yang
Phone
+86-020-34403854
Email
caoy2008@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cao Yang
Organizational Affiliation
Guangzhou Red Cross Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Guangzhou Red cross hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Bing
Phone
020-34403854
Email
27291375@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25859171
Citation
Kako H, Gable A, Martin D, Beebe A, Thung A, Samora W, Klamar J, Bhalla T, Tobias JD. A prospective, open-label trial of clevidipine for controlled hypotension during posterior spinal fusion. J Pediatr Pharmacol Ther. 2015 Jan-Feb;20(1):54-60. doi: 10.5863/1551-6776-20.1.54.
Results Reference
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PubMed Identifier
23162401
Citation
Amr YM, Amin SM. Effects of preoperative beta-blocker on blood loss and blood transfusion during spinal surgeries with sodium nitroprusside-controlled hypotension. Saudi J Anaesth. 2012 Jul;6(3):263-7. doi: 10.4103/1658-354X.101219.
Results Reference
background
Learn more about this trial
Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery
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