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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

Tracking Information
First Submitted Date  ICMJE September 30, 2012
First Posted Date  ICMJE October 4, 2012
Results First Submitted Date  ICMJE February 26, 2013
Results First Posted Date  ICMJE November 27, 2014
Last Update Posted Date November 27, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)		 The time from the discontinuation 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • The time from the discontinuation 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 discontinuation 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimization of Desflurane in Elderly Patients
Official Title  ICMJE Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Desflurane
  • 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.
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)		 20
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700907
Other Study ID Numbers  ICMJE DES-40-POCD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michiaki Yamakage, Sapporo Medical University
Study Sponsor  ICMJE Sapporo Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michiaki Yamakage, M.D.,PhD Sapporo Medical University, School of Medicine
PRS Account Sapporo Medical University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP