Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimization of Desflurane in Elderly Patients

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.
 
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Postoperative Cognitive Dysfunction
Interventions Drug: Desflurane
Drug: Sevoflurane
Enrollment 20
Recruitment Details Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.
Pre-assignment Details

Inclusion criteria were shown as follows: Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients.

Exclusion criteria were shown as follows: Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients (BMI>35)

Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Group DES Group SEVO Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
10
 100.0%
10
 100.0%
20
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
74.9  (6.0) 74.1  (6.5) 74.5  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
5
  50.0%
10
  50.0%
Male
5
  50.0%
5
  50.0%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title The Time From the End of Anesthesia to Extubation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is a pilot study.
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: second
329.0
(296.2 to 453.0)
636.0
(613.5 to 918.8)
2.Secondary Outcome
Title The Time From the End of Anesthesia to Eye Opening
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is a pilot study.
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: second
176.5
(166.0 to 317.0)
315.0
(277.2 to 404.8)
3.Secondary Outcome
Title The Time From the End of Anesthesia to Following Commands
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is a pilot study.
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: second
246.5
(169.1 to 357.3)
424.0
(352.3 to 553.0)
4.Secondary Outcome
Title Cognitive Function
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is a pilot study
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
pre-operation
28.0
(27.0 to 29.0)
28.0
(27.5 to 29.0)
post-operation
29.5
(28.0 to 30.0)
29.0
(28.3 to 30.0)
5.Secondary Outcome
Title The Incidence of Postoperative Delirium
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is a pilot study.
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame The adverse event will be evaluated at 24 h after surgery by interviewing.
Adverse Event Reporting Description The adverse event is defined as follows: postoperative death, re-operation, hypotension (systolic blood pressure under 80 mmHg), and delirium at 24 h after surgery. If the adverse event occur and recover until 24 h after surgery, the adverse event is not counted. Other adverse event is not assessed.
 
Arm/Group Title Group DES Group SEVO
Hide Arm/Group 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.
All-Cause Mortality
Group DES Group SEVO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group DES Group SEVO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group DES Group SEVO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michiaki Yamakage
Organization: Sapporo Medical University School of Medicine
Phone: +81116112111 ext 3568
EMail: yamakage@sapmed.ac.jp
Layout table for additonal information
Responsible Party: Michiaki Yamakage, Sapporo Medical University
ClinicalTrials.gov Identifier: NCT01700907    
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