- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985854
Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Makoto Ozaki, Ph.D
- Phone Number: 28290 81-3-3353-8111
- Email: mozaki@anes.twmu.ac.jp
Study Locations
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Tokyo, Japan, 1628666
- Tokyo Women's Medical University Hospital
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Contact:
- Makoto Ozaki, Ph.D
- Phone Number: 28290 81-3-3353-8111
- Email: mozaki@anes.twmu.ac.jp
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Contact:
- Kasuya Yusuke, Ph.D
- Phone Number: 29472 81-3-3353-8111
- Email: kasuyay@mb.infoweb.ne.jp
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Principal Investigator:
- Makoto Ozaki, M.D, Ph.D
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Sub-Investigator:
- Yusuke Kasuya, M.D, Ph.D
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Sub-Investigator:
- Nobutada Morioka, M.D, Ph.D
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Sub-Investigator:
- Shunichi Takagi, M.D, Ph.D
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Sub-Investigator:
- Maho Kinoshita, M.D.
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Sub-Investigator:
- Mirei Nagai, M.D, Ph.D
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Sub-Investigator:
- Yoshikazu Okada, M.D, Ph.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
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Study Plan
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 |
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Active Comparator: Propofol
Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure.
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Other Names:
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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.
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Other Names:
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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.
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Patients will be followed in the operation room, an expected average of 30 minutes.
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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
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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
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Cognitive function
Time Frame: Up to 24 hours
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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.
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Up to 24 hours
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Time from the discontinuation of anesthesia to orientation
Time Frame: Up to 24 hours
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Time from the discontinuation of anesthesia to orientation (State name, state the date of birth)
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Up to 24 hours
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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
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Patients will be followed for the duration of intensive care unit stay, an expected average of 1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Makoto Ozaki, Ph.D, Tokyo Women's Mecical University, Department of Anesthesiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIVA DES conversion
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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