NCT02766062

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
Last Updated

June 30, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

May 1, 2016

Last Update Submit

June 29, 2016

Conditions

Postoperative Complications

Keywords

Postoperative cognitive dysfunctionmetabolic syndromepropofolsevoflurane

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

metabolic syndromeOTHER

metabolic syndrome

propofol groupsevoflurane group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative ComplicationsPostoperative Cognitive ComplicationsMetabolic Syndrome

Interventions

ANAPC16 protein, human

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 9, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

safety