POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

September 8, 2014 updated by: Richard Applegate, Loma Linda University

Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial

The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

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

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda 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

Sampling Method

Non-Probability Sample

Study Population

Adult patients, male and female, 65 years or older scheduled for elective surgery requiring general anesthesia.

Description

Inclusion Criteria:

  • Adult patients (>65 years old)
  • Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
  • Airway management expected to include endotracheal intubation
  • Expected surgical duration 120 to 240 minutes

Exclusion Criteria:

  • Pre-existing significant psychiatric disease or mental status changes
  • Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease

  • Patient's weighing >50% ideal body weight

    • Men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet
    • Women: Ideal Body Weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet
  • Patients who have undergone a general anesthetic within the past 7 days
  • Patient refusal

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
desflurane and sevoflurane
Subjects will be randomized to either desflurane or sevoflurane. They will be given the Mini Mental State exam at 1, 6 and 24 hours after the end of anesthesia.
Other: The intervention will be Mini-Mental Status Examination (MMSE)
A questionnaire given to the study patient before and after the anesthetic at 1, 6 and 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
Time Frame: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.
The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.
Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome measures will include: 1) time to extubation, anesthetic complications (e.g. coughing during extubation), 2) time to readiness for discharge from PACU, 3) length of hospital stay, and 4) any postoperative complications.
Time Frame: 24 hours to 7 days
24 hours to 7 days

Collaborators and Investigators

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

Sponsor

Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5100193

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.

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