Comparison of Postoperative Outcome After Sevoflurane and... | NCT02931877

Studies
Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

NCT02931877

Sponsor

Xinqiao Hospital of Chongqing

Status

Completed

Last Update Posted

Jul 10, 2018Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Postoperative Cognitive Dysfunction

Interventions

sevoflurane
propofol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Oct 10, 2016

First Submission Date that Met QC Criteria

Oct 12, 2016

First Posted Date

Oct 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2018

Last Update Posted Date

Jul 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Li, Director, Department of Anesthesiology, Xinqiao Hospital of ChongqingPrincipal Investigator

Lead Sponsor

Xinqiao Hospital of ChongqingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
sevoflurane	Drug		Sevoflurane
propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Postoperative delirium (POD)	POD is evaluated by a commonly used questionnaire	Up to 7 days after the surgery

Other Outcomes

Measure	Description	Time Frame
Degree of increase of stress hormones	Stress hormones include S-100β, Il-6, etc.	Up to 24 hours after the surgery
Length of ICU stay	The time for patient stay in ICU

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Li, M.D.	Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinan Hospital, Third Military Medical University		Chongqing	Chongqing Municipality	400037	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000079690	Postoperative Cognitive Complications

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D060825	Cognitive Dysfunction

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D015742	Propofol

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided