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Completed

NCT Number: NCT02691416

Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

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

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Key information

Conditions

Cerebral Arterial Aneurysm

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

propofol postconditioning

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

Drug

0.5%-2% sevoflurane with BIS 40-60

Primary outcomes

  1. Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit

    Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery

    Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical

  2. Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA

    Time frame: before induction, after clamping removal,operation ending,1,3,7days post surgery

    Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation

  3. Evidences of Clinically Definite Oxidative Stress:Micronuclei

    Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery

    Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test

  4. Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography

    Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery

    Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.

  5. Evidences of Clinically Definite Oxidative Stress: Nuclear Buds

    Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery

    Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test

  6. Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges

    Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery

    Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test

Secondary outcomes

  1. Mini Mental State Examination (MMSE)

    Time frame: before induction,1,3,7days post surgery

    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: before induction,1,3,7days post surgery

    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.

Sponsors and collaborators

Lead sponsor

The Third Central Clinical College of Tianjin Medical University

Other

Registry information

Official study title

Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function in Patients Undergoing Intracranial Aneurysm Surgery.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 25, 2016
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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