The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
Primary Purpose
Total Intravenous Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mild hypercapnia
Sponsored by
About this trial
This is an interventional treatment trial for Total Intravenous Anesthesia focused on measuring hypercapnia, recovery time, total intravenous anesthesia
Eligibility Criteria
Inclusion Criteria:
- Adult patients aged 20-60 years, with American Society of Anesthesiology physical status 1 to 2, undergoing transurethral lithotripsy under TIVA with endotracheal intubation; voluntarily signed informed consent forms.
Exclusion Criteria:
- Patients with mental, pulmonary, cardiac, endocrine, neuromuscular, liver and nervous system diseases or a history of such diseases; Lung CT showed atelectasis, pulmonary infection and pleural effusion. Patients taking sedatives or other drugs that might interfere with the study; Alcohol or drug dependence; Patients who have had a history of general anesthesia within the past month; Patients with body mass index (BMI) of 30 kg/m2 or above; Patients who are expected to be under anesthesia for less than 30 minutes; Patients with difficult airways.
Sites / Locations
- 2ndAffiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
normal blood carbonic acid level
mild hypercapnia
Arm Description
After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored.
After propofol infusion was stopped, ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored.
Outcomes
Primary Outcome Measures
Tracheal extubation time
The time from propofol infusion stopped to Tracheal extubation
Secondary Outcome Measures
Time of anesthesia
Time from anesthesia induction to cessation of propofol infusion
Total infusion of propofol and remifentanil
Total infusion of propofol and remifentanil
Spontaneous respiratory recovery time
The time from the beginning of cessation of propofol infusion to the time when the patient begins to cough or when the ETCO2 waveform changes
Time of eyes or mouth opening
The time from the beginning of cessation of propofol infusion to the time when patients can open their eyes or mouth
Changes in cerebral blood flow examined by transcranial Doppler (TCD)
Examine at the following four time points: before anesthesia induction; 10min after operation; After adjustment of ETCO2 is completed in post-anaesthesia care unit(PACU); 20 min after tracheal extubation
Full Information
NCT ID
NCT05401266
First Posted
May 26, 2022
Last Updated
February 10, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05401266
Brief Title
The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
Official Title
The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
Detailed Description
At present, there is no effective intervention method for the recovery of general anesthesia, and the elimination of anesthetic agents, especially from the brain is a decisive factor in the emergence from general anesthesia. Many studies have reported the effect of hypercapnia on recovery time from volatile anesthetics. Hypercapnia can increase cardiac output and cerebral blood flow, increasing the ability to remove volatile anesthetics from the brain and shortening the recovery time from anesthesia.
Propofol is becoming the most common intravenous agent used for induction as well as maintenance of total intravenous anesthesia (TIVA). Its rapid elimination from the blood and brain is expected to shorten the recovery time from TIVA. Only a few clinical studies have investigated the relationship between hypercapnia and emergence time with propofol anesthesia. But those studies may have been influenced by postoperative pain, so the recovery time cannot reflect propofol metabolism alone. Moreover, intraoperative hypercapnia may increase the need for intraoperative anesthetic agents by increasing the clearance of agents from the brain.
As a non-invasive method, Transcranial Doppler ultrasonography(TCD)can be used to monitor blood flow changes in different parts of cerebral arterial circle(Willis circle), and its safety and effectiveness in perioperative related fields have been proved.
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Intravenous Anesthesia
Keywords
hypercapnia, recovery time, total intravenous anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal blood carbonic acid level
Arm Type
No Intervention
Arm Description
After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored.
Arm Title
mild hypercapnia
Arm Type
Experimental
Arm Description
After propofol infusion was stopped, ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored.
Intervention Type
Procedure
Intervention Name(s)
mild hypercapnia
Intervention Description
Ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored
Primary Outcome Measure Information:
Title
Tracheal extubation time
Description
The time from propofol infusion stopped to Tracheal extubation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time of anesthesia
Description
Time from anesthesia induction to cessation of propofol infusion
Time Frame
1 year
Title
Total infusion of propofol and remifentanil
Description
Total infusion of propofol and remifentanil
Time Frame
1 year
Title
Spontaneous respiratory recovery time
Description
The time from the beginning of cessation of propofol infusion to the time when the patient begins to cough or when the ETCO2 waveform changes
Time Frame
1 year
Title
Time of eyes or mouth opening
Description
The time from the beginning of cessation of propofol infusion to the time when patients can open their eyes or mouth
Time Frame
1 year
Title
Changes in cerebral blood flow examined by transcranial Doppler (TCD)
Description
Examine at the following four time points: before anesthesia induction; 10min after operation; After adjustment of ETCO2 is completed in post-anaesthesia care unit(PACU); 20 min after tracheal extubation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients aged 20-60 years, with American Society of Anesthesiology physical status 1 to 2, undergoing transurethral lithotripsy under TIVA with endotracheal intubation; voluntarily signed informed consent forms.
Exclusion Criteria:
Patients with mental, pulmonary, cardiac, endocrine, neuromuscular, liver and nervous system diseases or a history of such diseases; Lung CT showed atelectasis, pulmonary infection and pleural effusion. Patients taking sedatives or other drugs that might interfere with the study; Alcohol or drug dependence; Patients who have had a history of general anesthesia within the past month; Patients with body mass index (BMI) of 30 kg/m2 or above; Patients who are expected to be under anesthesia for less than 30 minutes; Patients with difficult airways.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Liu, Master
Phone
+86 13958033523
Email
zrll@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li Na Yu, Professor
Phone
+86 13958033387
Email
zryulina@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li Fang, PhD
Organizational Affiliation
Study Official Affiliation
Official's Role
Study Director
Facility Information:
Facility Name
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Liu, Master
Phone
+86 13958033523
Email
zrll@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Li Na Yu, PhD
Phone
+86 13958033387
Email
zryulina@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
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