Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

NCT ID: NCT03129009

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-06-01

Brief Summary

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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

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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.

Conditions

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Balanced Anesthesia Intracerebral Hemorrhage Total Intravenous Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Total intravenous anesthesia group

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

Group Type ACTIVE_COMPARATOR

Total intravenous anesthesia group

Intervention Type DRUG

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

Balanced anesthesia group

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

Group Type EXPERIMENTAL

Balanced anesthesia group

Intervention Type DRUG

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

Interventions

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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 Type 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

Intervention Type DRUG

Other Intervention Names

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TIVA Balanced anesthesia

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jin Dong Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Dong Liu, M.S

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Dong Liu, M.S

Role: CONTACT

+86-13951355136

Facility Contacts

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Jin Dong Liu, M.S

Role: primary

+86-13951355136

References

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Other Identifiers

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XYFY-2017-008

Identifier Type: -

Identifier Source: org_study_id

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