Optimization of Desflurane in Elderly Patients

NCT01700907 | Completed Phase 1 Results DMC

• 1 other identifier: DES-40-POCD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Cognitive Dysfunction

Keywords

Postoperative cognitive dysfunction; elderly patients; long surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Time From the End of Anesthesia to Eye Opening

  Within 60 minutes after the end of anesthesia

• The Time From the End of Anesthesia to Following Commands

  Within 60 minutes after the end of anesthesia

• Cognitive Function

  24 hrs pre and postoperatively

• The Incidence of Postoperative Delirium

  from 15 minutes to 48 hrs postoperatively

Study Arms (2)

group DES

ACTIVE COMPARATOR

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

Drug: Desflurane

group SEVO

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

Desflurane DRUG

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

Also known as: (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane

group DES

Sevoflurane DRUG

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

Also known as: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane

group SEVO

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients

You may not qualify if:

• \- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)

Sponsors & Collaborators

• Sapporo Medical University: lead

Study Sites (1)

Sapporo Medical University, School of Medicine

Sappro, Hokkaido, 0608556, Japan

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Desflurane; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Michiaki Yamakage
• Organization: Sapporo Medical University School of Medicine

yamakage@sapmed.ac.jp

+81116112111

Study Officials

• Michiaki Yamakage, M.D.,PhD

  Sapporo Medical University, School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study

Study Record Dates

• First Submitted: September 30, 2012
• First Posted: October 4, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 27, 2014
• Results First Posted: November 27, 2014

Record last verified: 2014-11

Locations

JP (1)