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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03317535
Other study ID # 2017-10-15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2018
Est. completion date June 23, 2021

Study information

Verified date May 2023
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is few randomized controlled clinical to investigated the impact of anesthetic type on outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is unknown whether the choice of anesthesia is impacted on the outcomes for these patients or not. The investigators will perform a randomized controlled pilot clinical trial of general anesthesia versus local anesthesia/conscious sedation to explore and find out a potential fact whether anesthetic type alters perioperative neurological function in patients with acute ischemic stroke in posterior cerebral circulation.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date June 23, 2021
Est. primary completion date June 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age > 18; The onset time is within 24 hours; Modified rankin score =2 before onset. Exclusion Criteria: - Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; Severe agitation or seizures on admission; Obvious loss of airway protective reflexes and/or vomiting on admission; Being intubated before treatment on admission; Known allergy to anesthetic or analgesic;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
General anesthesia
Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.
Local anesthesia/concious sedation
Patients will be injected with propofol and remifentanil.
Spontaneous breath
Patients will be kept spontaneous breath.
Controlled ventilation
Patient will be kept with controlled ventilation.

Locations

Country Name City State
China Ruquan Han Fengtai Beijing
China Fan Wang Guiyang Guizhou

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified rankin score(mRS) Modified rankin score(mRS)is used to evaluate the primary outcome. The scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS=2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcomes assessor who is blinded to the grouping. post-procedural 90 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06453252 - Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study
Active, not recruiting NCT05906420 - Posterior Circulation ASTRAL Prognostic Score
Recruiting NCT05897554 - Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP) N/A