The Effect of Desflurane on Postopertative Cognitive Dysfunction

August 15, 2021 updated by: Anshi Wu, Beijing Chao Yang Hospital

A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction

The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction

Study Overview

Detailed Description

Postoperative cognitive dysfunction is a common complication during postoperative period,especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.

Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Written consent given
  • 2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
  • 3. ASA Physical Score I-III

Exclusion Criteria:

  • 1. Patients with a history of neurological disease, such as Alzheimer disease.
  • 2. Patients with a history of psychiatric disease
  • 3. Patients with a medication history of antipsychotic drugs.
  • 4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
  • 5. Patients with preoperative delirium.
  • 6. Patients who have severe adverse events, such as cardiac arrest.
  • 7. Patients who preoperative MMSE score are below 20;
  • 8. Patients who undergo second operation in a short period.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Desflurane
Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
PLACEBO_COMPARATOR: Propofol
Patients allocated to this arm will receive propofol during the maintenance of anesthesia
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative cognitive dysfunction
Time Frame: on the 30th day after surgery
Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery
on the 30th day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative nausea and vomiting
Time Frame: Within 7 days after surgery
Within 7 days after surgery
Incidence of postoperative delirium
Time Frame: 1-7days after surgery, on the 30th day after surgery
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
1-7days after surgery, on the 30th day after surgery
Postoperative Pain
Time Frame: Within 3 days after surgery
Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
Within 3 days after surgery
EEG frequency spectrum
Time Frame: 5 minutes before anesthesia introduction to 5 minutes before discharge from PACU

Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB:

  1. Five minutes before anesthesia introduction
  2. During the entire operation
  3. At discharge from post-anesthesia care unit (PACU)
5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
Mortality
Time Frame: Within 30 days after surgery
Within 30 days after surgery
Length of Hospital stay
Time Frame: From the date of admission until discharged from hospital, within 30 days
From the date of admission until discharged from hospital, within 30 days
Hospital readmission
Time Frame: Within 30 days after surgery
Hospital readmission during the follow up
Within 30 days after surgery
Adverse events
Time Frame: Within 30 days after surgery
Other adverse events within 3 days after surgery were noted
Within 30 days after surgery
Neural and hemodynamic responses during desflurane general anesthesia
Time Frame: 5 minutes before anesthesia introduction to 5 minutes after emergence
Functional near-infrared spectroscopy (fNIRS) will be monitored from pre-anesthesia to the emergence. △[HbO] ,△[Hb] will be recorded. Besides, the coupling of fNIRS signals with neuronal signals (EEG) will be calculated. Furthermore, sample entrophy and the phase difference between △[HbO] and △[Hb] will be measured.
5 minutes before anesthesia introduction to 5 minutes after emergence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Delirium

Clinical Trials on Desflurane

3
Subscribe