Completed

Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery

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What is being tested

Sevoflurane

+ remifentanil

+ propofol

Drug
Who is being recruted

From 60 to 100 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorSun Yat-sen University
Last updated: June 22, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) sevoflurane-based general anesthesia group, and 2) propofol-based general anesthesia group. Each group will need 221 patients to detect 1/3 of decrease or increase in the rate of POCD of one group compared with another group at about one week after surgery, assuming the overall rate of POCD at this time is about 40% at this time. Considering about 10% loss to follow-up, we will have 250 patients in each group. In addition, investigators will need 184 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.

NCT01809041
Principal SponsorSun Yat-sen University
Last updated: June 22, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

684 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed
major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are >= 60 years old
the surgery is laparoscopic surgery and is expected to last for >= 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery
8 exclusion criteria prevent from participating
Mini-mental State Examination (MMSE) [18] score <= 23
Patients are not expected to be alive for longer than 3 months
alcoholism and drug dependence
current use of sedatives or antidepressant
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

Group II

Active Comparator
propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sun Yat-Sen Memorial Hospital

Guangzhou, ChinaOpen Sun Yat-Sen Memorial Hospital in Google Maps
CompletedOne Study Center