Evaluating the Use of 0.5 and 0.75 MAC Desflurane in Patients Undergoing Spinal Surgery

NCT04717102 | Completed Phase 4

• 1 other identifier: Desflurane01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Somatosensory- (SSEPs) and motor-evoked potentials (MEPs) are commonly used as an intraoperative neurophysiologic monitoring tool to detect aberrations to the spinal cord integrity during spinal surgery. Inhalational anaesthetic agents have a significant influence on evoked potentials by suppressing the amplitude and prolonging the latency. Evidences suggest that total intravenous anaesthesia (TIVA) is superior to inhalation anaesthesia for neuromonitoring in spinal surgery, and support the use of up to 0.5 minimum alveolar concentration (MAC) of inhalational anaesthetic agents in these procedures. Methods: Patients undergoing spinal surgeries will be prospectively recruited and be induced with TIVA at baseline of the evoked potentials. They will be randomized to receive balance anaesthesia with A) Desflurane MAC 0.5+remifentanil, or B) Desflurane MAC 0.75+remifentanil until the end of surgery. Influence of 1.0 MAC desflurane on the evoked potentials after the completion of surgery will also be studied. Desired Results: Endpoints include the changes to the amplitude and latency of SSEPs and MEPs with 0.5 and 0.75 MAC desflurane. The findings will indicate the safety of desflurane at the studied concentrations for spinal surgeries, and substantial savings with the use of desflurane instead of TIVA.

Conditions

Anesthesia

Keywords

evoked potentials; spinal surgery; desflurane

Outcome Measures

Primary Outcomes (6)

• Effect of 0.5 MAC desflurane on evoked potentials - Amplitude (microvolts)

  Amplitude of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane

  During surgery

• Effect of 0.5 MAC desflurane on evoked potentials - Latency (milliseconds)

  Latency of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane

  During surgery

• Effect of 0.5 MAC desflurane on evoked potentials - Morphology (appearance of the response)

  Morphology of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane

  During surgery

• Effect of 0.75 MAC desflurane on evoked potentials - Amplitude (microvolts)

  Amplitude of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane

  During surgery

• Effect of 0.75 MAC desflurane on evoked potentials - Latency (milliseconds)

  Latency of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane

  During surgery

• Effect of 0.75 MAC desflurane on evoked potentials - Morphology (appearance of the response)

  Morphology of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane

  During surgery

Secondary Outcomes (3)

• Effect of 1.0 MAC desflurane on evoked potentials - Amplitude (microvolts)

  intraoperative

• Effect of 1.0 MAC desflurane on evoked potentials - Latency (milliseconds)

  intraoperative

• Effect of 1.0 MAC desflurane on evoked potentials - Morphology (appearance of the response)

  intraoperative

Study Arms (2)

0.75 MAC desflurane

EXPERIMENTAL

The effects of 0.75 MAC desflurane on the amplitude and latency of evoked potentials in spinal surgeries will be examined.

Drug: 0.75 MAC desflurane; Drug: 1.0 MAC desflurane

0.5 MAC desflurane

ACTIVE COMPARATOR

The effects of 0.5 MAC desflurane on the amplitude and latency of evoked potentials in spinal surgeries will be examined.

Drug: 0.5 MAC desflurane; Drug: 1.0 MAC desflurane

Interventions

0.5 MAC desflurane DRUG

Following induction of anesthesia by propofol, the patients will be maintained on 0.5 MAC desflurane with remifentanil infusion during spinal surgery.

Also known as: 0.5 MAC desflurane (Suprane)

0.5 MAC desflurane

0.75 MAC desflurane DRUG

Following induction of anesthesia by propofol, the patients will be maintained on 0.75 MAC desflurane with remifentanil infusion during spinal surgery.

Also known as: 0.75 MAC desflurane (Suprane)

0.75 MAC desflurane

1.0 MAC desflurane DRUG

On completion of the neuromonitoring phase of surgery, the patients will be maintained on 1.0 MAC desflurane with remifentanil infusion.

Also known as: 1.0 MAC desflurane (Suprane)

0.5 MAC desflurane; 0.75 MAC desflurane

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 21 years old, scheduled for spinal surgery.
• Patients who require SSEP/MEP and with no neurological deficits.
• Patients of American Society of Anesthesiologist I-III physical status.
• Consenting patients.
• Elective procedures.

You may not qualify if:

• Patients with sensory or motor deficits preoperatively.
• Patients with significant cardiovascular and/or respiratory disease.
• Emergency procedures.
• Cord injury secondary to trauma.
• Non-consenting patients.
• Category A patients (Prisoners).
• Patients with previous stroke.
• Patients with Hep C, HIV.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (3)

• Hasan MS, Tan JK, Chan CYW, Kwan MK, Karim FSA, Goh KJ. Comparison between effect of desflurane/remifentanil and propofol/remifentanil anesthesia on somatosensory evoked potential monitoring during scoliosis surgery-A randomized controlled trial. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018789529. doi: 10.1177/2309499018789529.

  PMID: 30058437 BACKGROUND

• Sloan TB, Toleikis JR, Toleikis SC, Koht A. Intraoperative neurophysiological monitoring during spine surgery with total intravenous anesthesia or balanced anesthesia with 3% desflurane. J Clin Monit Comput. 2015 Feb;29(1):77-85. doi: 10.1007/s10877-014-9571-9. Epub 2014 Mar 19.

  PMID: 24643708 BACKGROUND

• Macdonald DB, Skinner S, Shils J, Yingling C; American Society of Neurophysiological Monitoring. Intraoperative motor evoked potential monitoring - a position statement by the American Society of Neurophysiological Monitoring. Clin Neurophysiol. 2013 Dec;124(12):2291-316. doi: 10.1016/j.clinph.2013.07.025. Epub 2013 Sep 18.

  PMID: 24055297 BACKGROUND

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Wai May Leong, MMed

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: April 14, 2021
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)