Optimization of Desflurane in Elderly Patients

• 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: Sapporo Medical University
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Group DES	Group SEVO	Total
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
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

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This is a pilot study.

Arm/Group Title	Group DES	Group SEVO
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
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

Outcome Measure Data

Analysis Population Description

This is a pilot study.

Arm/Group Title	Group DES	Group SEVO
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
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

Outcome Measure Data

Analysis Population Description

This is a pilot study.

Arm/Group Title	Group DES	Group SEVO
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
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

Outcome Measure Data

Analysis Population Description

This is a pilot study

Arm/Group Title	Group DES	Group SEVO
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
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

Outcome Measure Data

Analysis Population Description

This is a pilot study.

Arm/Group Title	Group DES	Group SEVO
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

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	Group DES	Group SEVO
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/10 (0.00%)	0/10 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Michiaki Yamakage
• Organization: Sapporo Medical University School of Medicine
• Phone: +81116112111 ext 3568
• EMail: yamakage@sapmed.ac.jp

• 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