NCT02691416

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 2, 2016

Completed
Last Updated

July 11, 2017

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 3, 2016

Results QC Date

April 7, 2016

Last Update Submit

June 10, 2017

Conditions

Cerebral Arterial Aneurysm

Outcome Measures

Primary Outcomes (6)

  • Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit

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

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

  • Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA

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

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

  • Evidences of Clinically Definite Oxidative Stress:Micronuclei

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

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

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

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

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

  • Evidences of Clinically Definite Oxidative Stress: Nuclear Buds

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

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

  • Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges

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

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

Secondary Outcomes (2)

  • Mini Mental State Examination (MMSE)

    before induction,1,3,7days post surgery

  • Montreal Cognitive Assessment (MoCA)

    before induction,1,3,7days post surgery

Study Arms (2)

propofol postconditioning

EXPERIMENTAL

1.2mg/L propofol

Drug: propofol postconditioningDrug: sevoflurane

sevoflurane

EXPERIMENTAL

0.5%-2% sevoflurane

Drug: sevoflurane

Interventions

propofol postconditioningDRUG

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

propofol postconditioning
sevofluraneDRUG

0.5%-2% sevoflurane with BIS 40-60

propofol postconditioningsevoflurane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Results Point of Contact

Title
Dr.Haiyun Wang
Organization
The Third Central Clinical College of Tianjin Medical University, Tianjin the Third Central Hospital
why819@126.com
13752211206

Study Officials

  • Haiyun Wang

    The Third Central Clinical College of Tianjin Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 25, 2016

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

July 11, 2017

Results First Posted

September 2, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share