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Optimization of Desflurane in Elderly Patients

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ClinicalTrials.gov Identifier: NCT01700907
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : November 27, 2014
Last Update Posted : November 27, 2014
Sponsor:
Information provided by (Responsible Party):
Michiaki Yamakage, Sapporo Medical University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Drug: Desflurane Drug: Sevoflurane Phase 1 Phase 2

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Japan
Sapporo Medical University, School of Medicine
Sappro, Hokkaido, Japan, 0608556
Sponsors and Collaborators
Sapporo Medical University
Investigators
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Principal Investigator: Michiaki Yamakage, M.D.,PhD Sapporo Medical University, School of Medicine
More Information
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Responsible Party: Michiaki Yamakage, Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study, Sapporo Medical University
ClinicalTrials.gov Identifier: NCT01700907    
Other Study ID Numbers: DES-40-POCD
First Posted: October 4, 2012    Key Record Dates
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:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Sevoflurane
Desflurane
 Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs