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

NCT01985854 | Unknown Phase 4

• 1 other identifier: TIVA DES conversion
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Elective Craniotomy

Keywords

Desflurane; Propofol; Total intravenous anesthesia; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Time from the discontinuation of anesthesia to extubation

  Patients will be followed in the operation room, an expected average of 30 minutes.

Secondary Outcomes (3)

• 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

• Cognitive function

  Up to 24 hours

• Time from the discontinuation of anesthesia to orientation

  Up to 24 hours

Other Outcomes (1)

• Length of ICU stay

  Patients will be followed for the duration of intensive care unit stay, an expected average of 1 week

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Desflurane

EXPERIMENTAL

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

Interventions

Propofol DRUG

Also known as: Diprivan

Propofol

Desflurane DRUG

Also known as: Suprane

Desflurane

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Tokyo Women's Medical University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Tokyo Women's Medical University Hospital

Tokyo, Tokyo, 1628666, Japan

Location

MeSH Terms

Interventions

Propofol; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Makoto Ozaki, Ph.D

  Tokyo Women's Mecical University, Department of Anesthesiology

  STUDY CHAIR

Central Study Contacts

Makoto Ozaki, Ph.D

CONTACT

81-3-3353-8111; mozaki@anes.twmu.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: November 15, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

JP (1)