Effects of Propofol and Sevoflurane on Early POCD in Elde... | NCT02766062

Studies
Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome

NCT02766062

Sponsor

General Hospital of Ningxia Medical University

Status

Completed

Last Update Posted

Jun 30, 2016Estimated

Enrollment

94Actual

Phase

Not Applicable

Conditions

Postoperative Complications

Interventions

metabolic syndrome

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

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

Sep 2015

Primary Completion Date

Apr 2016Actual

Completion Date

May 2016Actual

First Submitted Date

May 1, 2016

First Submission Date that Met QC Criteria

May 6, 2016

First Posted Date

May 9, 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

Jun 29, 2016

Last Update Posted Date

Jun 30, 2016Estimated

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

The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Detailed Description

By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propofol group	Active Comparator	Patients with metabolic syndrome were randomly assigned to receive propofol anesthesia	Other: metabolic syndrome
sevoflurane group	Active Comparator	Patients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia	Other: metabolic syndrome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metabolic syndrome	Other	metabolic syndrome	propofol group sevoflurane group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group		up to 7days postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged ≥60 years;
ASAⅡor Ⅲ
noncardiac surgery and nonneural surgery

Exclusion Criteria:

Mini Mental State Examination [MMSE] score too low
chronic alcoho and drug abuse
disturbed renal and liver function
history of a cerebrovascular accident
permanent ventricular pacing
preoperative cognitive deficits
lack of cooperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

safety

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 12, 2016
Unrelease		Yes
Release	Aug 4, 2016
Reset	Sep 21, 2016

Submission Tracking

Estimated Results First Submitted Date

Jul 12, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 12, 2016		Yes
Aug 4, 2016

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D000079690	Postoperative Cognitive Complications
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D060825	Cognitive Dysfunction
D003072	Cognition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C539689	ANAPC16 protein, human

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided