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Optimization of Desflurane in Elderly Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michiaki Yamakage, Sapporo Medical University
ClinicalTrials.gov Identifier:
NCT01700907
First received: September 30, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing.

Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia.

The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).


Condition Intervention Phase
Postoperative Cognitive Dysfunction
 Drug: Desflurane
Drug: Sevoflurane
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sapporo Medical University:

Primary Outcome Measures:
  • The time from the discontinuation of anesthesia to extubation [ Time Frame: Within 60 minutes after the end of anesthesia ] [ Designated as safety issue: No ]
    When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.


Secondary Outcome Measures:
  • The time from the discontinuation of anesthesia to eye opening [ Time Frame: Within 60 minutes after the end of anesthesia ] [ Designated as safety issue: No ]
    When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.

  • The time from the discontinuation of anesthesia to following commands [ Time Frame: Within 60 minutes after the end of anesthesia ] [ Designated as safety issue: No ]
    When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.

  • Cognitive function [ Time Frame: 24 hrs pre and postoperatively ] [ Designated as safety issue: No ]
    cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively.

  • The incidence of postoperative delirium [ Time Frame: from 15 minutes to 48 hrs postoperatively ] [ Designated as safety issue: No ]
    The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.


Study Start Date: August 2012
Arms Assigned Interventions
Active Comparator: DES
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
 Drug: Desflurane
Active Comparator: SEVO
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
 Drug: Sevoflurane

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700907

Locations
Japan
Sapporo Medical University, School of Medicine
Sappro, Hokkaido, Japan, 0608556
Sponsors and Collaborators
Sapporo Medical University
Investigators
Principal Investigator: Michiaki Yamakage, M.D.,PhD Sapporo Medical University, School of Medicine
  More Information

No publications provided

Responsible Party: Michiaki Yamakage, Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study, Sapporo Medical University
ClinicalTrials.gov Identifier: NCT01700907     History of Changes
Other Study ID Numbers: DES-40-POCD
Study First Received: September 30, 2012
Last Updated: October 2, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Sapporo Medical University:
Postoperative cognitive dysfunction
elderly patients
long surgery

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

ClinicalTrials.gov processed this record on May 16, 2013