Optimization of Desflurane in Elderly Patients

• Sponsor: Sapporo Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01700907
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 3.3

Study Details

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).

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

• Study Type: Interventional
• 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: Aug 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

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 Names: (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 Names: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane

Outcome Measures

Primary Outcome Measures

1. The Time From the End of Anesthesia to Extubation [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sapporo Medical University, School of Medicine	Sappro	Hokkaido	Japan	0608556

Sponsors and Collaborators

• Sapporo Medical University

Investigators

• Principal Investigator: Michiaki Yamakage, M.D.,PhD, Sapporo Medical University, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 4, 2012
• Last Update Posted: Nov 27, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Michiaki Yamakage, Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study, Sapporo Medical University: Postoperative cognitive dysfunction; elderly patients; long surgery
• Additional relevant MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction; Sevoflurane; Desflurane

Study Results

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 Detail	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 Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	10 100%	10 100%	20 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.9 (6.0)	74.1 (6.5)	74.5 (6.1)
Sex: Female, Male (Count of Participants)
Female	5 50%	5 50%	10 50%
Male	5 50%	5 50%	10 50%
Region of Enrollment (participants) [Number]
Japan	10 100%	10 100%	20 100%

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.
Measure Participants	10	10
Median (Inter-Quartile Range) [second]	329.0	636.0

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.
Measure Participants	10	10
Median (Inter-Quartile Range) [second]	176.5	315.0

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.
Measure Participants	10	10
Median (Inter-Quartile Range) [second]	246.5	424.0

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.
Measure Participants	10	10
pre-operation	28.0	28.0
post-operation	29.5	29.0

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.
Measure Participants	10	10
Number [participants]	2 20%	0 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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group DES		Group SEVO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Group DES		Group SEVO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.