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Optimization of Desflurane in Elderly Patients

NCT ID: NCT01700907

Last Updated: 2014-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-02-28

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)

Conditions

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Postoperative Cognitive Dysfunction

Keywords

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Postoperative cognitive dysfunction elderly patients long surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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 Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.

Interventions

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Desflurane

The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.

Intervention Type DRUG

Sevoflurane

The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.

Intervention Type DRUG

Other Intervention Names

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(2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane

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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sapporo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Michiaki Yamakage

Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michiaki Yamakage, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

Sapporo Medical University, School of Medicine

Locations

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Sapporo Medical University, School of Medicine

Sappro, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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DES-40-POCD

Identifier Type: -

Identifier Source: org_study_id