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Optimization of Desflurane in Elderly Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700907
First Posted: October 4, 2012
Last Update Posted: November 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michiaki Yamakage, Sapporo Medical University
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Michiaki Yamakage, Sapporo Medical University:

Primary Outcome Measures:
  • The Time From the End of Anesthesia to Extubation [ Time Frame: Within 60 minutes after the end of anesthesia ]
    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 End of Anesthesia to Eye Opening [ Time Frame: Within 60 minutes after the end of anesthesia ]
    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 End of Anesthesia to Following Commands [ Time Frame: Within 60 minutes after the end of anesthesia ]
    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 ]
    Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.

  • The Incidence of Postoperative Delirium [ Time Frame: from 15 minutes to 48 hrs postoperatively ]
    The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.


Enrollment: 20
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 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
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
Other Name: (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane
Active Comparator: group 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
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Other Name: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane

Detailed Description:

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

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 30, 2012
First Posted: October 4, 2012
Results First Submitted: February 26, 2013
Results First Posted: November 27, 2014
Last Update Posted: November 27, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anesthetics
Sevoflurane
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General