Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

Carotid Stenosis Clinical Trial

Official title:

Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function in Patients Undergoing Carotid Endarterectomy and Cerebral Aneurysmectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691416
• Other study ID #: ThirdCCCTianjin
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2016
• Last updated: February 21, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: The Third Central Clinical College of Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the CEA and Cerebral Aneurysmectomy about antioxidant effect.

Description:

CEA and Cerebral Aneurysmectomy 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of CEA or Cerebral Aneurysmectomy ,

• American Society of Anesthesiologists (ASA)?-?.

Exclusion Criteria:

• severe hepatic and renal dysfunction

• coagulation disorder

• taking antioxidant perioperative period

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Arterial Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• propofol
0.5%-2% sevoflurane and 1.2mg/L propofol (TCI)
• sevoflurane
0.5%-2% sevoflurane with BIS 40-60

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Central Clinical College of Tianjin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidences of clinically definite oxidative stress confirmed by ELIASA kit	Evidences of clinically definite oxidative stress :Superoxide dismutase activity,a- tocopherol, ?- tocopherol,8-isoprostane, Hydroxyl radical	7days post surgery	Yes
Primary	Evidences of clinically definite oxidative stress confirmed by high performance liquid chromatography	Evidences of clinically definite oxidative stress:a- tocopherol, ?- tocopherol	7days post surgery	Yes
Primary	Evidences of clinically definite oxidative stress confirmed by Cytokinesis-block Micronucleus Test	Evidences of clinically definite oxidative stress:micronuclei, nuclear buds and nucleoplasmic bridges	7days post surgery	Yes
Secondary	Mini Mental State Examination (MMSE)	A questionnaires is used to asseess the cognitive function of patients in clinical	7days post surgery	Yes
Secondary	Montreal Cognitive Assessment (MoCA)	A questionnaires is used to asseess the cognitive function of patients in clinical	7days post surgery	Yes