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POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Martin Allard, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01199913
First received: September 9, 2010
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
1. Postoperative Cognitive Dysfunction
 Other: The intervention will be Mini-Mental Status Examination (MMSE)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199913

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
  More Information

No publications provided

Responsible Party: Martin Allard, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01199913     History of Changes
Other Study ID Numbers: 5100193
Study First Received: September 9, 2010
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
problems with thinking after surgery;

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
Desflurane
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 21, 2013