Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

Not Applicable

• Conditions: Balanced Anesthesia; Intracerebral Hemorrhage; Total Intravenous Anesthesia
• Interventions: Drug: Balanced anesthesia group; Drug: Total intravenous anesthesia group

• Registration Number: NCT03129009
• Lead Sponsor: Xuzhou Medical University

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Status Verified: 2017-04
• Study Start: 2017-04-01
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-26
• Last Update Posted: 2017-04-26
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced 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
Total intravenous anesthesia group	Total intravenous anesthesia group	Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion

Primary Outcome Measures

Name	Time	Method
MAP changes relative to the changes before induction	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 Outcome Measures

Name	Time	Method
Acute renal failure	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)
Troponin T	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
CK-MB release level	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.
Serum creatinine	24 hour, 48 hour,72 hour post surgery	Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour
All-cause mortality	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.

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China