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

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ClinicalTrials.gov Identifier: NCT01985854
Recruitment Status : Unknown
Verified November 2013 by Makoto Ozaki, Tokyo Women's Medical University.
Recruitment status was:  Not yet recruiting
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Makoto Ozaki, Tokyo Women's Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Patients Undergoing Elective Craniotomy Drug: Propofol Drug: Desflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery: A Pilot Study for Assessment of Recovery Parameters
Study Start Date : January 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propofol
Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure.
Drug: Propofol
Other Name: 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.
Drug: Desflurane
Other Name: Suprane




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

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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)


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


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985854


Contacts
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Contact: Makoto Ozaki, Ph.D 81-3-3353-8111 ext 28290 mozaki@anes.twmu.ac.jp

Locations
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Japan
Tokyo Women's Medical University Hospital Not yet recruiting
Tokyo, Japan, 1628666
Contact: Makoto Ozaki, Ph.D    81-3-3353-8111 ext 28290    mozaki@anes.twmu.ac.jp   
Contact: Kasuya Yusuke, Ph.D    81-3-3353-8111 ext 29472    kasuyay@mb.infoweb.ne.jp   
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         
Sponsors and Collaborators
Tokyo Women's Medical University
Baxter Healthcare Corporation
Investigators
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Study Chair: Makoto Ozaki, Ph.D Tokyo Women's Mecical University, Department of Anesthesiology

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Responsible Party: Makoto Ozaki, Professor, Tokyo Women's Medical University
ClinicalTrials.gov Identifier: NCT01985854    
Other Study ID Numbers: TIVA DES conversion
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by Makoto Ozaki, Tokyo Women's Medical University:
Desflurane
Propofol
Total intravenous anesthesia
Neurosurgery
Additional relevant MeSH terms:
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Anesthetics
Propofol
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation