Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

Study 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.

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

Conditions
-----------------
Balanced Anesthesia, Intracerebral Hemorrhage, Total Intravenous Anesthesia

Intervention / Treatment
-----------------
* Drug: Total intravenous anesthesia group
* Drug: Balanced anesthesia group


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total intravenous anesthesia group<br>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<br>* Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion<br>* Other names: TIVA;|
| Experimental: Balanced anesthesia group<br>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<br>* Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation<br>* 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 | 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 | 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 | 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 | 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 | 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 | Serum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour | 24 hour, 48 hour,72 hour post surgery |