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Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03129009
Enrollment
90
Registered
2017-04-26
Start date
2017-04-01
Completion date
2018-06-01
Last updated
2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balanced Anesthesia, Intracerebral Hemorrhage, Total Intravenous Anesthesia

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.

Interventions

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

DRUGBalanced anesthesia group

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

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
MAP changes relative to the changes before inductionIntraoperativeMAP 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

MeasureTime frameDescription
All-cause mortality7 days post surgeryAll-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.
Acute renal failure7 days post surgeryIncreased 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)
CK-MB release level6 hour, 12 hour,24 hour,48 hour post surgeryClinically, 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.
Troponin T6 hour, 12 hour, 24 hour, 48 hour post surgeryThe levels of troponin T were released before anesthesia induction at 6 hour, 12 hour, 24 hour and 48 hour
Serum creatinine24 hour, 48 hour,72 hour post surgerySerum creatinine levels were measured before and after anesthesia induction at 24 hour, 48 hour

Countries

China

Contacts

Primary ContactJin Dong Liu, M.S
liujindong1818@163.com+86-13951355136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026