Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

NCT ID: NCT02691416

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.

Detailed Description

intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats.

As for sevoflurane, some investigation indicated that sevoflurane is able to reduce oxidative stress in cell(except neuronal cell lines ) and rodent models, but the antioxidant effect did not found in human minor incision surgeries, furthermore, oxidative stress was raised in the major surgeries including orthopedic surgeries, hysterectomy, cholecystectomy, and thoracotomy

Conditions

Cerebral Arterial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

propofol postconditioning

1.2mg/L propofol

Group Type: EXPERIMENTAL

propofol postconditioning

Intervention Type: DRUG

administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal

sevoflurane

Intervention Type: DRUG

0.5%-2% sevoflurane with BIS 40-60

sevoflurane

0.5%-2% sevoflurane

Group Type: EXPERIMENTAL

sevoflurane

Intervention Type: DRUG

0.5%-2% sevoflurane with BIS 40-60

Interventions

propofol postconditioning

administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal

Intervention Type: DRUG

sevoflurane

0.5%-2% sevoflurane with BIS 40-60

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis intracranial aneurysm surgery ,
• American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

Exclusion Criteria

• severe hepatic and renal dysfunction
• coagulation disorder
• taking antioxidant perioperative period

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Central Clinical College of Tianjin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haiyun Wang

Role: STUDY_DIRECTOR

The Third Central Clinical College of Tianjin Medical University

Other Identifiers

ThirdCCCTianjin

Identifier Type: -

Identifier Source: org_study_id