Changi General Hospital
Singapore, 529889
NCT Number: NCT04717102
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.
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Notify Me21 year–99 year
All sexes
Interventional
Phase 4
Singapore, 529889
Recording of Evoked Potentials characteristics:
The following characteristics of the evoked potential signals will be recorded:
Anaesthesia variables:
At the time of recording of evoked potentials:
Patient characteristics:
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:
Group A- Anaesthesia maintained with 0.5 MAC desflurane/remifentanil infusion Group B- Anaesthesia maintained with 0.75MAC desflurane/remifentanil infusion
All patients will get additional analgesics and antiemetics as deemed necessary. Post-operative recovery will follow the standard industry norms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following induction of anesthesia by propofol, the patients will be maintained on 0.5 MAC desflurane with remifentanil infusion during spinal surgery.
Other names: 0.5 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.
Other names: 0.75 MAC desflurane (Suprane)
On completion of the neuromonitoring phase of surgery, the patients will be maintained on 1.0 MAC desflurane with remifentanil infusion.
Other names: 1.0 MAC desflurane (Suprane)
Time frame: During surgery
Amplitude of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Time frame: During surgery
Latency of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Time frame: During surgery
Morphology of somatosensory- and motor- evoked potentials with use of 0.5 MAC desflurane
Time frame: During surgery
Amplitude of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
Time frame: During surgery
Latency of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
Time frame: During surgery
Morphology of somatosensory- and motor- evoked potentials with use of 0.75 MAC desflurane
Time frame: intraoperative
Amplitude of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Time frame: intraoperative
Latency of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Time frame: intraoperative
Morphology of somatosensory- and motor- evoked potentials with use of 1.0 MAC desflurane
Changi General Hospital
Other
Evaluating the Use of Desflurane in Patients Undergoing Spinal Surgery: A Randomized Controlled Trial Using 0.5 and 0.75 MAC Desflurane
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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