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Completed

NCT Number: NCT01700907

Optimization of Desflurane in Elderly Patients

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).

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sapporo Medical University, School of Medicine

Sappro, Hokkaido, 0608556, Japan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Desflurane

Drug

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

Sevoflurane

Drug

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

Primary outcomes

  1. The Time From the End of Anesthesia to Extubation

    Time frame: 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 outcomes

  1. The Time From the End of Anesthesia to Eye Opening

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sapporo Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Nov 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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