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

Patients Undergoing Elective Craniotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01985854
• Other study ID #: TIVA DES conversion
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 7, 2013
• Last updated: November 9, 2013
• Start date: January 2014

Study information

• Verified date: November 2013
• Source: Tokyo Women's Medical University
• Contact: Makoto Ozaki, Ph.D
• Phone: 81-3-3353-8111
• Email: mozaki[@]anes.twmu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective craniotomy

• American Society of Anesthesiology Physical Status ?, 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients Undergoing Elective Craniotomy

Intervention

Drug:
• Propofol

• Desflurane

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical University Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Tokyo Women's Medical University	Baxter Healthcare Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of ICU stay		Patients will be followed for the duration of intensive care unit stay, an expected average of 1 week	No
Primary	Time from the discontinuation of anesthesia to extubation		Patients will be followed in the operation room, an expected average of 30 minutes.	No
Secondary	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	No
Secondary	Cognitive function	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	No
Secondary	Time from the discontinuation of anesthesia to orientation	Time from the discontinuation of anesthesia to orientation (State name, state the date of birth)	Up to 24 hours	No