Optimization of Desflurane in Elderly Patients

Study Overview
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Brief Summary
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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
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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)

Official Title
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Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: Desflurane
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group DES<br>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. | Drug: Desflurane<br>* The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.<br>* Other names: (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane;|
| Active Comparator: group SEVO<br>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. | Drug: Sevoflurane<br>* The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.<br>* Other names: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 60 minutes after the end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 60 minutes after the end of anesthesia | 
| 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. | Within 60 minutes after the end of anesthesia | 
| 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. | 24 hrs pre and postoperatively | 
| 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. | from 15 minutes to 48 hrs postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative cognitive dysfunction, elderly patients, long surgery