Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery

November 9, 2013 updated by: Makoto Ozaki, Tokyo Women's Medical University

Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery: A Pilot Study for Assessment of Recovery Parameters

Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation.

We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Tokyo, Japan, 1628666
        • Tokyo Women's Medical University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Makoto Ozaki, M.D, Ph.D
        • Sub-Investigator:
          • Yusuke Kasuya, M.D, Ph.D
        • Sub-Investigator:
          • Nobutada Morioka, M.D, Ph.D
        • Sub-Investigator:
          • Shunichi Takagi, M.D, Ph.D
        • Sub-Investigator:
          • Maho Kinoshita, M.D.
        • Sub-Investigator:
          • Mirei Nagai, M.D, Ph.D
        • Sub-Investigator:
          • Yoshikazu Okada, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective craniotomy
  • American Society of Anesthesiology Physical Status Ⅰ, II and III
  • Age: between 20 to 65 years
  • Sex: male or female
  • Patients who are postmenopausal or surgically sterilized
  • Expected Operation time is longer than 4 hours.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure.
Other Names:
  • Diprivan
Experimental: Desflurane
After taking off the electrophysiological monitoring from the patients, discontinue propofol and start desflurane from 6% (dialed concentration) at flow rate of 4L/min for 2 minutes in desflurane group. When achieve end tidal concentration of 4-5%, decrease the flow rate to 2L/min.
Other Names:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from the discontinuation of anesthesia to extubation
Time Frame: Patients will be followed in the operation room, an expected average of 30 minutes.
Patients will be followed in the operation room, an expected average of 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from the discontinuation of anesthesia to eye opening
Time Frame: At the end of surgery, duration time from the discontinuation of anesthesia to the eye opening will be measured, averaged expected time is 30 minutes
At the end of surgery, duration time from the discontinuation of anesthesia to the eye opening will be measured, averaged expected time is 30 minutes
Cognitive function
Time Frame: Up to 24 hours
Cognitive function will be measured by Mini-Mental state examination at baseline (preoperatively) 5 minutes and 24 hours after extubation. Postoperative recovery function will be also measured by Post-operative Quality Recovery Scale (PQRS scale) at 5 minutes and 24 hours after extubation.
Up to 24 hours
Time from the discontinuation of anesthesia to orientation
Time Frame: Up to 24 hours
Time from the discontinuation of anesthesia to orientation (State name, state the date of birth)
Up to 24 hours

Other Outcome Measures

Outcome Measure
Time Frame
Length of ICU stay
Time Frame: Patients will be followed for the duration of intensive care unit stay, an expected average of 1 week
Patients will be followed for the duration of intensive care unit stay, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Makoto Ozaki, Ph.D, Tokyo Women's Mecical University, Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

November 9, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 9, 2013

Last Verified

November 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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