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

NCT ID: NCT01985854

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Undergoing Elective Craniotomy

Keywords

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Desflurane Propofol Total intravenous anesthesia Neurosurgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol

Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Desflurane

Intervention Type DRUG

Other Intervention Names

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Diprivan Suprane

Eligibility Criteria

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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

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Tokyo Women's Medical University

OTHER

Sponsor Role lead

Responsible Party

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Makoto Ozaki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Makoto Ozaki, Ph.D

Role: STUDY_CHAIR

Tokyo Women's Mecical University, Department of Anesthesiology

Locations

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Tokyo Women's Medical University Hospital

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Central Contacts

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Makoto Ozaki, Ph.D

Role: CONTACT

Phone: 81-3-3353-8111

Email: [email protected]

Facility Contacts

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Makoto Ozaki, Ph.D

Role: primary

Kasuya Yusuke, Ph.D

Role: backup

Other Identifiers

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TIVA DES conversion

Identifier Type: -

Identifier Source: org_study_id