Trial Outcomes & Findings for Optimization of Desflurane in Elderly Patients (NCT NCT01700907)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Within 60 minutes after the end of anesthesia

Results posted on

2014-11-27

Participant Flow

Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.

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)

Participant milestones

Participant milestones
Measure	Group DES The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimization of Desflurane in Elderly Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	74.9 years STANDARD_DEVIATION 6.0 • n=5 Participants	74.1 years STANDARD_DEVIATION 6.5 • n=7 Participants	74.5 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Japan	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 60 minutes after the end of anesthesia

Population: This is a pilot study.

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.

Outcome measures

Outcome measures
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
The Time From the End of Anesthesia to Extubation	329.0 second Interval 296.2 to 453.0	636.0 second Interval 613.5 to 918.8

SECONDARY outcome

Timeframe: Within 60 minutes after the end of anesthesia

Population: This is a pilot study.

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.

Outcome measures

Outcome measures
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
The Time From the End of Anesthesia to Eye Opening	176.5 second Interval 166.0 to 317.0	315.0 second Interval 277.2 to 404.8

SECONDARY outcome

Timeframe: Within 60 minutes after the end of anesthesia

Population: This is a pilot study.

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.

Outcome measures

Outcome measures
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
The Time From the End of Anesthesia to Following Commands	246.5 second Interval 169.1 to 357.3	424.0 second Interval 352.3 to 553.0

SECONDARY outcome

Timeframe: 24 hrs pre and postoperatively

Population: This is a pilot study

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.

Outcome measures

Outcome measures
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Cognitive Function pre-operation	28.0 Scores on a scale Interval 27.0 to 29.0	28.0 Scores on a scale Interval 27.5 to 29.0
Cognitive Function post-operation	29.5 Scores on a scale Interval 28.0 to 30.0	29.0 Scores on a scale Interval 28.3 to 30.0

SECONDARY outcome

Timeframe: from 15 minutes to 48 hrs postoperatively

Population: This is a pilot study.

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

Outcome measures

Outcome measures
Measure	Group DES n=10 Participants The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.	Group SEVO n=10 Participants The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
The Incidence of Postoperative Delirium	2 participants	0 participants

Adverse Events

Group DES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group SEVO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michiaki Yamakage

Sapporo Medical University School of Medicine

Phone: +81116112111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place