NCT02931877

Brief Summary

As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

October 10, 2016

Last Update Submit

July 9, 2018

Conditions

Postoperative Cognitive Dysfunction

Keywords

SevofluranePropofolCardiac valvular surgeryCardiopulmonary bypassPostoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Number of patients with postoperative cognitive dysfunction (POCD)

    POCD is a composite outcome measure

    From 7 days after the surgery to the day of discharge from hospital

Secondary Outcomes (1)

  • Postoperative delirium (POD)

    Up to 7 days after the surgery

Other Outcomes (3)

  • Degree of increase of stress hormones

    Up to 24 hours after the surgery

  • Length of ICU stay

    Up to 7 days after the surgery

  • Length of hospital stay

    Up to 3 months after the surgery

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.

Drug: sevoflurane

Propofol

ACTIVE COMPARATOR

Maintenance of anesthesia propofol during the cardiac valvular surgery.

Drug: propofol

Interventions

sevofluraneDRUG
Sevoflurane
propofolDRUG
Propofol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who receive cardiac valvular surgery
  • to 65 years
  • American society of anesthesiologists classification Ⅱto Ⅲ
  • education level higher than elementary school

You may not qualify if:

  • Patients are not expected to be alive for longer than 3 months.
  • Mini-mental State Examination (MMSE) score ≤ 23.
  • current use of sedatives or antidepressant
  • history of dementia, psychiatric illness or any diseases of central nervous system.
  • accompanying liver or kidney function deficiency
  • history of some endocrine disease
  • alcoholism and drug dependence
  • patients previously included in this study or currently included in the other clinical study
  • patients who have second surgery during the study period
  • difficult to follow up or patients with poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xinan Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Hong Li, M.D.

    Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Anesthesiology

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

CN(3)