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Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

Primary Purpose

Balanced Anesthesia, Intracerebral Hemorrhage, Total Intravenous Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total intravenous anesthesia group
Balanced anesthesia group
Sponsored by
Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Balanced Anesthesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years to90 years.
  2. acute stroke symptoms caused by initial spontaneous intracerebral hemorrhage as determined by CT or MRI Blood: the screen area: 30-50ml; cerebellum parts:> 10ml.
  3. GCS score> 5 points

Exclusion Criteria:

  1. ICH is caused by other factors (anticoagulation associated with cerebral hemorrhage, arteriovenous malformations, tumors)
  2. intracerebral hematoma is thought to be associated with trauma (simple intracerebral hemorrhage)
  3. there are surgical contraindications.
  4. history of ischemic stroke
  5. acute spontaneous intracerebral hemorrhage before the presence of dementia or limb dysfunction (paralysis or aphasia.
  6. preoperative combined with chronic kidney disease (standard for glomerular filtration rate below 60 ml · min-1 · 1.73 m2 or received dialysis).
  7. anesthesia time shorter than 60 min or lack of relevant basic information.
  8. while there is interference with the experimental results or follow-up of the disease (tumor, severe cardiovascular disease).

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Total intravenous anesthesia group

Balanced anesthesia group

Arm Description

Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion

Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation

Outcomes

Primary Outcome Measures

MAP changes relative to the changes before induction
MAP changes relative to the changes before induction; <20%, 20% -30%, 30% -40%,> 40%MAP changes relative to the changes before induction; <20%, 20% -30%, 30% -40%,> 40%

Secondary Outcome Measures

All-cause mortality
All-cause mortality is the ratio of the total number of deaths resulting from a variety of causes over a period of time to the average population of the population over the same period.
Acute renal failure
Increased absolute serum creatinine ≥0.3mg / dl (≥26.5μmol / l), or ≥50% increase (1.5 times the baseline), or urine <0.5ml / (kg.h) for more than 6 hours Obstructive nephropathy or dehydration status)
CK-MB release level
Clinically, CK-MB more than the total activity of CK 3 (ion exchange column chromatography) or 10 (immunosuppressive method) as the basis for the diagnosis of acute myocardial infarction.
Troponin T
The levels of troponin T were released before anesthesia induction at 6 hour, 12 hour, 24 hour and 48 hour
Serum creatinine
Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour

Full Information

First Posted
March 29, 2017
Last Updated
April 20, 2017
Sponsor
Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03129009
Brief Title
Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage
Official Title
Changes of Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage During Different General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical 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
Spontaneous non-traumatic intracerebral hemorrhage (ICH) is a common symptom in clinical practice and is the most serious among all types of stroke.Recently, as a relatively mainstream and recognized INTERACT2 (five well-known international studies in the cerebrovascular field: IMS-III, MR RESCUE, SYNTHESIS EXPANSION, INTERACT2, CHANCE) studies have shown that in patients with standard systolic blood pressure Early intensive antihypertensive therapy does not increase the incidence of death or serious adverse events. The above studies confirm the safety and efficacy of early potent depression.In 2017, Anesthesiology published a META analysis of intraoperative hypotension and blood pressure versus baseline fluctuations. The final outcome showed that 20% of blood pressure in the study was similar to MAP <65 mmHg, regardless of the duration of the duration There will be postoperative myocardial and renal damage. Ischemia is a very important cause of organ damage. Myocardial injury is closely related to the level of mean arterial pressure, while ischemia and ischemic reperfusion injury are closely related to postoperative acute renal injury.There is no targeted guideline for ICH perioperative blood pressure management, especially intraoperative blood pressure management, and no previous studies have studied most of the studies involving ICH patients with conservative treatment, ICH patients with surgical treatment There are few reports on blood pressure control during surgery.
Detailed Description
The general anesthesia used in craniotomy, whether intravenous anesthesia or total intravenous anesthesia, have a certain degree of blood pressure and lead to a decline in blood pressure, the study aims to spontaneous cerebral hemorrhage this special And to observe the changes of hemodynamics and the changes of heart and kidney function in ICH, and to explore the relationship between the anesthesia and the blood of ICH. The range of volatility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balanced Anesthesia, Intracerebral Hemorrhage, Total Intravenous Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total intravenous anesthesia group
Arm Type
Active Comparator
Arm Description
Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
Arm Title
Balanced anesthesia group
Arm Type
Experimental
Arm Description
Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation
Intervention Type
Drug
Intervention Name(s)
Total intravenous anesthesia group
Other Intervention Name(s)
TIVA
Intervention Description
Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
Intervention Type
Drug
Intervention Name(s)
Balanced anesthesia group
Other Intervention Name(s)
Balanced anesthesia
Intervention Description
Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation
Primary Outcome Measure Information:
Title
MAP changes relative to the changes before induction
Description
MAP changes relative to the changes before induction; <20%, 20% -30%, 30% -40%,> 40%MAP changes relative to the changes before induction; <20%, 20% -30%, 30% -40%,> 40%
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality is the ratio of the total number of deaths resulting from a variety of causes over a period of time to the average population of the population over the same period.
Time Frame
7 days post surgery
Title
Acute renal failure
Description
Increased absolute serum creatinine ≥0.3mg / dl (≥26.5μmol / l), or ≥50% increase (1.5 times the baseline), or urine <0.5ml / (kg.h) for more than 6 hours Obstructive nephropathy or dehydration status)
Time Frame
7 days post surgery
Title
CK-MB release level
Description
Clinically, CK-MB more than the total activity of CK 3 (ion exchange column chromatography) or 10 (immunosuppressive method) as the basis for the diagnosis of acute myocardial infarction.
Time Frame
6 hour, 12 hour,24 hour,48 hour post surgery
Title
Troponin T
Description
The levels of troponin T were released before anesthesia induction at 6 hour, 12 hour, 24 hour and 48 hour
Time Frame
6 hour, 12 hour, 24 hour, 48 hour post surgery
Title
Serum creatinine
Description
Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour
Time Frame
24 hour, 48 hour,72 hour post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years to90 years. acute stroke symptoms caused by initial spontaneous intracerebral hemorrhage as determined by CT or MRI Blood: the screen area: 30-50ml; cerebellum parts:> 10ml. GCS score> 5 points Exclusion Criteria: ICH is caused by other factors (anticoagulation associated with cerebral hemorrhage, arteriovenous malformations, tumors) intracerebral hematoma is thought to be associated with trauma (simple intracerebral hemorrhage) there are surgical contraindications. history of ischemic stroke acute spontaneous intracerebral hemorrhage before the presence of dementia or limb dysfunction (paralysis or aphasia. preoperative combined with chronic kidney disease (standard for glomerular filtration rate below 60 ml · min-1 · 1.73 m2 or received dialysis). anesthesia time shorter than 60 min or lack of relevant basic information. while there is interference with the experimental results or follow-up of the disease (tumor, severe cardiovascular disease).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Dong Liu, M.S
Phone
+86-13951355136
Email
liujindong1818@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Dong Liu, M.S
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Dong Liu, M.S
Phone
+86-13951355136
Email
liujindong1818@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available when this trial is finished and the article have been published
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Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

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