Clinical trial NCT03129009: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Balanced Anesthesia
Intracerebral Hemorrhage
Total Intravenous Anesthesia
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: MAP changes relative to the changes before induction
timeFrame: Intraoperative
Secondary outcomes:
measure: All-cause mortality
timeFrame: 7 days post surgery
measure: Acute renal failure
timeFrame: 7 days post surgery
measure: CK-MB release level
timeFrame: 6 hour, 12 hour,24 hour,48 hour post surgery
measure: Troponin T
timeFrame: 6 hour, 12 hour, 24 hour, 48 hour post surgery
measure: Serum creatinine
timeFrame: 24 hour, 48 hour,72 hour post surgery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Jin Dong Liu, M.S
role: PRINCIPAL_INVESTIGATOR
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