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Optimization of Desflurane in Elderly Patients

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Sponsored by
Sapporo Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Cognitive Dysfunction focused on measuring Postoperative cognitive dysfunction, elderly patients, long surgery

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sapporo Medical University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group DES

group SEVO

Arm Description

The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.

The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.

Outcomes

Primary Outcome Measures

The Time From the End of Anesthesia to Extubation
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
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
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
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
The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.

Full Information

First Posted
September 30, 2012
Last Updated
November 25, 2014
Sponsor
Sapporo Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01700907
Brief Title
Optimization of Desflurane in Elderly Patients
Official Title
Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sapporo Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Postoperative cognitive dysfunction, elderly patients, long surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group DES
Arm Type
Active Comparator
Arm Description
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
Arm Title
group SEVO
Arm Type
Active Comparator
Arm Description
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
(2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane
Intervention Description
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane
Intervention Description
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Primary Outcome Measure Information:
Title
The Time From the End of Anesthesia to Extubation
Description
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.
Time Frame
Within 60 minutes after the end of anesthesia
Secondary Outcome Measure Information:
Title
The Time From the End of Anesthesia to Eye Opening
Description
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.
Time Frame
Within 60 minutes after the end of anesthesia
Title
The Time From the End of Anesthesia to Following Commands
Description
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.
Time Frame
Within 60 minutes after the end of anesthesia
Title
Cognitive Function
Description
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.
Time Frame
24 hrs pre and postoperatively
Title
The Incidence of Postoperative Delirium
Description
The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.
Time Frame
from 15 minutes to 48 hrs postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiaki Yamakage, M.D.,PhD
Organizational Affiliation
Sapporo Medical University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sapporo Medical University, School of Medicine
City
Sappro
State/Province
Hokkaido
ZIP/Postal Code
0608556
Country
Japan

12. IPD Sharing Statement

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Optimization of Desflurane in Elderly Patients

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