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

Phase 4

• Conditions: Patients Undergoing Elective Craniotomy
• Interventions: Drug: Propofol; Drug: Desflurane

• Registration Number: NCT01985854
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-07
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-09
• Last Update Submitted: 2013-11-09
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15
• Study Start: 2014-01
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time from the discontinuation of anesthesia to extubation	Patients will be followed in the operation room, an expected average of 30 minutes.

Secondary Outcome Measures

Name	Time	Method
Cognitive function	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.
Time from the discontinuation of anesthesia to eye opening	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
Time from the discontinuation of anesthesia to orientation	Up to 24 hours	Time from the discontinuation of anesthesia to orientation (State name, state the date of birth)

Trial Locations

Locations (1)

Tokyo Women's Medical University Hospital; 🇯🇵 Tokyo, Japan