Optimization of Desflurane in Elderly Patients

Phase 1

Completed

Conditions: Postoperative Cognitive Dysfunction

Interventions: Drug: Desflurane
Drug: Sevoflurane

Registration Number: NCT01700907

Lead Sponsor: Sapporo Medical University

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).

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group DES	Desflurane	The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
group SEVO	Sevoflurane	The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.