Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

April 20, 2017 updated by: Jin Dong Liu, Xuzhou Medical University

Changes of Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage During Different General Anesthesia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Total intravenous anesthesia group
Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
Drug: Total intravenous anesthesia group
Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
Other Names:
  • TIVA
Experimental: Balanced anesthesia group
Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation
Drug: Balanced anesthesia group
Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation
Other Names:
  • Balanced anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAP changes relative to the changes before induction
Time Frame: Intraoperative
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%
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 7 days post surgery
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.
7 days post surgery
Acute renal failure
Time Frame: 7 days post surgery
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)
7 days post surgery
CK-MB release level
Time Frame: 6 hour, 12 hour,24 hour,48 hour post surgery
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.
6 hour, 12 hour,24 hour,48 hour post surgery
Troponin T
Time Frame: 6 hour, 12 hour, 24 hour, 48 hour post surgery
The levels of troponin T were released before anesthesia induction at 6 hour, 12 hour, 24 hour and 48 hour
6 hour, 12 hour, 24 hour, 48 hour post surgery
Serum creatinine
Time Frame: 24 hour, 48 hour,72 hour post surgery
Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour
24 hour, 48 hour,72 hour post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Investigators

  • Principal Investigator: Jin Dong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY-2017-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be available when this trial is finished and the article have been published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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