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Clinical Trials/NCT03129009
NCT03129009
Unknown
Not Applicable

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

Xuzhou Medical University1 site in 1 country90 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Total intravenous anesthesia group
Conditions
Balanced Anesthesia
Sponsor
Xuzhou Medical University
Enrollment
90
Locations
1
Primary Endpoint
MAP changes relative to the changes before induction
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
June 1, 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jin Dong Liu

Principal Investigator

Xuzhou Medical University

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).

Arms & Interventions

Total intravenous anesthesia group

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

Intervention: Total intravenous anesthesia group

Balanced anesthesia group

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

Intervention: Balanced anesthesia group

Outcomes

Primary Outcomes

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%

Secondary Outcomes

  • Acute renal failure(7 days post surgery)
  • Troponin T(6 hour, 12 hour, 24 hour, 48 hour post surgery)
  • CK-MB release level(6 hour, 12 hour,24 hour,48 hour post surgery)
  • Serum creatinine(24 hour, 48 hour,72 hour post surgery)
  • All-cause mortality(7 days post surgery)

Study Sites (1)

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