AnesthesiaPhase 4NCT04717102
Evaluating the Use of 0.5 and 0.75 MAC Desflurane in Patients Undergoing Spinal Surgery
A Phase 4 study testing 0.5 MAC desflurane, 0.75 MAC desflurane and 1.0 MAC desflurane in people with Anesthesia, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- 0.5 MAC desflurane, 0.75 MAC desflurane and 1.0 MAC desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Apr 2021to 27 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Desflurane in Patients Undergoing Spinal Surgery: A Randomized Controlled Trial Using 0.5 and 0.75 MAC Desflurane
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.
Read the detailed description
Recording of Evoked Potentials characteristics:
The following characteristics of the evoked potential signals will be recorded:
- Amplitude: Size of the response, measured in microvolts (μV)
- Latency: Speed of the response, measured in milliseconds (ms)
- Morphology: Appearance of the response - Simple/Complex wave shape Baseline evoked potentials will be recorded at various points of surgery.
Anaesthesia variables:
At the time of recording of evoked potentials:
- Intraoperative temperature, blood pressure, ETCO2, anaesthesia depth - bispectral index monitoring (BIS), remifentanil TCI, MAC of desflurane, Train of Four, volume of propofol and remifentanil until randomization, total volume of desflurane and remifentanil used, anaesthetic medications used, FiO2, SpO2
Patient characteristics:
- Age, gender, race, weight, BMI, medications used, haematocrit, preop blood glucose (for Diabetics)
Safety considerations:
'Recommended standards for intraoperative monitoring of somatosensory evoked potentials', Guideline 11B of the American Clinical Neurophysiology Society (2009) and 'Intraoperative motor evoked potential monitoring - A position statement by the American Society of Neurophysiological Monitoring' will form the basis of the safety aspects of the study.
Conduct of Anaesthesia:
- The induction of anaesthesia will be achieved using targeted propofol and remifentanil infusions (TIVA). Muscle relaxants atracurium, rocuronium or suxamethonium will be used to facilitate intubation.
- Anaesthesia will be maintained on TIVA until the patient has recovered from muscle relaxant. Baseline characteristics (BC1) of the evoked potentials in TIVA will be obtained at this stage.
- Once the BC1 has been obtained, the patients will be randomized to two groups:
Group A- Anaesthesia maintained with 0.5 MAC desflurane/remifentanil infusion Group B- Anaesthesia maintained with 0.75MAC desflurane/remifentanil infusion
- Baseline characteristics 2 (BC2) will be obtained and the decision to proceed with 0.5 or 0.75 MAC desflurane made.
- On completion of the neuromonitoring phase of surgery, as defined by completion of instrumentation and start of closure, all patients in Group A and B will be maintained with 1.0 MAC desflurane with remifentanil infusion. Baseline characteristics 3 (BC3) will be recorded at this stage.
- The remifentanil infusion will be titrated at various stages of surgery to maintain a stable BIS and will also be based on haemodynamic variables.
All patients will get additional analgesics and antiemetics as deemed necessary. Post-operative recovery will follow the standard industry norms.
- Conditions
- Anesthesia
- Being tested
- 0.5 MAC desflurane, 0.75 MAC desflurane, 1.0 MAC desflurane
- Keywords
- evoked potentials, spinal surgery, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 MAC desfluraneDrug
Also called 0.5 MAC desflurane (Suprane)
Following induction of anesthesia by propofol, the patients will be maintained on 0.5 MAC desflurane with remifentanil infusion during spinal surgery.
0.75 MAC desfluraneDrug
Also called 0.75 MAC desflurane (Suprane)
Following induction of anesthesia by propofol, the patients will be maintained on 0.75 MAC desflurane with remifentanil infusion during spinal surgery.
1.0 MAC desfluraneDrug
Also called 1.0 MAC desflurane (Suprane)
On completion of the neuromonitoring phase of surgery, the patients will be maintained on 1.0 MAC desflurane with remifentanil infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.5 MAC desflurane; Drug: 1.0 MAC desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During surgery
Secondary outcomes (3)
Effect of 1.0 MAC desflurane on evoked potentials - Amplitude (microvolts)
Amplitude of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Measured: intraoperative
Effect of 1.0 MAC desflurane on evoked potentials - Latency (milliseconds)
Latency of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Measured: intraoperative
Effect of 1.0 MAC desflurane on evoked potentials - Morphology (appearance of the response)
Morphology of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start14 Apr 2021
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leong Wai May, Changi General Hospital
- Investigators
- Wai May Leong, MMed, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717102
- Sponsor's protocol ID
- Desflurane01
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30058437Sloan 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.
PubMed 24643708Macdonald 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.
PubMed 24055297
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Desflurane in Patients Undergoing Spinal Surgery: A Randomized Controlled Trial Using 0.5 and 0.75 MAC Desflurane
- ClinicalTrials.gov ID
- NCT04717102
- Acronym / sponsor ID
- Desflurane01
- Conditions
- Anesthesia
- Keywords
- evoked potentials, spinal surgery, desflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recording of Evoked Potentials characteristics:
The following characteristics of the evoked potential signals will be recorded:
- Amplitude: Size of the response, measured in microvolts (μV)
- Latency: Speed of the response, measured in milliseconds (ms)
- Morphology: Appearance of the response - Simple/Complex wave shape Baseline evoked potentials will be recorded at various points of surgery.
Anaesthesia variables:
At the time of recording of evoked potentials:
- Intraoperative temperature, blood pressure, ETCO2, anaesthesia depth - bispectral index monitoring (BIS), remifentanil TCI, MAC of desflurane, Train of Four, volume of propofol and remifentanil until randomization, total volume of desflurane and remifentanil used, anaesthetic medications used, FiO2, SpO2
Patient characteristics:
- Age, gender, race, weight, BMI, medications used, haematocrit, preop blood glucose (for Diabetics)
Safety considerations:
'Recommended standards for intraoperative monitoring of somatosensory evoked potentials', Guideline 11B of the American Clinical Neurophysiology Society (2009) and 'Intraoperative motor evoked potential monitoring - A position statement by the American Society of Neurophysiological Monitoring' will form the basis of the safety aspects of the study.
Conduct of Anaesthesia:
- The induction of anaesthesia will be achieved using targeted propofol and remifentanil infusions (TIVA). Muscle relaxants atracurium, rocuronium or suxamethonium will be used to facilitate intubation.
- Anaesthesia will be maintained on TIVA until the patient has recovered from muscle relaxant. Baseline characteristics (BC1) of the evoked potentials in TIVA will be obtained at this stage.
- Once the BC1 has been obtained, the patients will be randomized to two groups:
Group A- Anaesthesia maintained with 0.5 MAC desflurane/remifentanil infusion Group B- Anaesthesia maintained with 0.75MAC desflurane/remifentanil infusion
- Baseline characteristics 2 (BC2) will be obtained and the decision to proceed with 0.5 or 0.75 MAC desflurane made.
- On completion of the neuromonitoring phase of surgery, as defined by completion of instrumentation and start of closure, all patients in Group A and B will be maintained with 1.0 MAC desflurane with remifentanil infusion. Baseline characteristics 3 (BC3) will be recorded at this stage.
- The remifentanil infusion will be titrated at various stages of surgery to maintain a stable BIS and will also be based on haemodynamic variables.
All patients will get additional analgesics and antiemetics as deemed necessary. Post-operative recovery will follow the standard industry norms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.75 MAC desflurane | Experimental | Drug: 0.75 MAC desflurane, Drug: 1.0 MAC desfluraneThe effects of 0.75 MAC desflurane on the amplitude and latency of evoked potentials in spinal surgeries will be examined. |
| 0.5 MAC desflurane | Active comparator | Drug: 0.5 MAC desflurane, Drug: 1.0 MAC desfluraneThe effects of 0.5 MAC desflurane on the amplitude and latency of evoked potentials in spinal surgeries will be examined. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 MAC desfluraneAlso: 0.5 MAC desflurane (Suprane)Following induction of anesthesia by propofol, the patients will be maintained on 0.5 MAC desflurane with remifentanil infusion during spinal surgery. | Drug | 0.5 MAC desflurane |
| 0.75 MAC desfluraneAlso: 0.75 MAC desflurane (Suprane)Following induction of anesthesia by propofol, the patients will be maintained on 0.75 MAC desflurane with remifentanil infusion during spinal surgery. | Drug | 0.75 MAC desflurane |
| 1.0 MAC desfluraneAlso: 1.0 MAC desflurane (Suprane)On completion of the neuromonitoring phase of surgery, the patients will be maintained on 1.0 MAC desflurane with remifentanil infusion. | Drug | 0.5 MAC desflurane, 0.75 MAC desflurane |
Primary outcome
Effect of 0.5 MAC desflurane on evoked potentials - Amplitude (microvolts)
Time frame: During surgery
Amplitude of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Effect of 0.5 MAC desflurane on evoked potentials - Latency (milliseconds)
Time frame: During surgery
Latency of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Effect of 0.5 MAC desflurane on evoked potentials - Morphology (appearance of the response)
Time frame: During surgery
Morphology of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Effect of 0.75 MAC desflurane on evoked potentials - Amplitude (microvolts)
Time frame: During surgery
Amplitude of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
Effect of 0.75 MAC desflurane on evoked potentials - Latency (milliseconds)
Time frame: During surgery
Latency of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
Effect of 0.75 MAC desflurane on evoked potentials - Morphology (appearance of the response)
Time frame: During surgery
Morphology of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
3 secondary outcomes
Effect of 1.0 MAC desflurane on evoked potentials - Amplitude (microvolts)
Time frame: intraoperative
Effect of 1.0 MAC desflurane on evoked potentials - Latency (milliseconds)
Time frame: intraoperative
Effect of 1.0 MAC desflurane on evoked potentials - Morphology (appearance of the response)
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 30058437Hasan 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.
- Background: PubMed 24643708Sloan 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.
- Background: PubMed 24055297Macdonald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai May Leong, MMed principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5 MAC desflurane, 0.75 MAC desflurane and 1.0 MAC desflurane in people with Anesthesia, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 0.5 MAC desflurane on evoked potentials - Amplitude (microvolts) (time frame: During surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.