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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02691416
Other study ID # ThirdCCCTianjin
Secondary ID
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


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
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