Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

A Comparative Study of Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

The objective of this study is to evaluate the effect of adding dexmedetomidine on evoked potentials in adult patients undergoing spinal surgery under intravenous anesthesia

Study Overview

• Status: Completed
• Conditions: Sevoflurane; Dexmedetomidine; Spine Surgery; Propofol; Fentanyl; Motor Evoked Potential; Somatosensory Evoked Potential
• Intervention / Treatment: Drug: Propofol-Fentanyl; Drug: Propofol-Fentanyl-Dexmedetomidine; Drug: Propofol-Fentanyl-Sevoflurane

Detailed Description

A catastrophic complication of spinal surgery is nerve and spinal cord injury. The incidence of neurological defects after spinal surgery can be reduced from 3.7%-6.9% to less than 1% with proper electrophysiological monitoring.

Somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) are currently used as adjunct diagnostic methods in spinal surgery, such as scoliosis surgery and spinal stenosis decompression.

Total intravenous anesthesia (TIVA) with propofol and opioids is commonly used in SEPs and MEPs monitoring as it causes increase in latency in comparison to inhalational anesthetics that cause decrease in amplitude .

The amplitudes of MEPs and SEPs are reduced by halogenated volatile anesthetics, limiting their use in spinal surgery that requires electrophysiological monitoring. When volatile anesthetics did not exceed 0.3MAC, they had little effect on MEPs and SEPs . Martin et al. discovered that volatile agent-based anesthesia has application value during neurophysiological monitoring, such as faster awakening and rapid wake-up tests.

As well, volatile anesthetics can reduce the dosage of propofol. As a result, spinal surgery benefits from combined intravenous inhalation anesthesia. As an adjuvant, dexmedetomidine may be useful in reducing the need for propofol.

Dexmedetomidine is a potent and highly selective alpha-2 agonist. It has the effect of sedation, analgesia, sympatholytic, minimal respiratory depression and possible neuroprotection. Its addition to the anesthetic regimen is believed to have the potential of sparing other hypnotics requirement, especially propofol, thus facilitating MEP and SSEP monitoring while providing the beneficial effects it has.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 21-45 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status II and III.
• Undergoing major spine surgery

Exclusion Criteria:

• Refusal of procedure or participation in the study by patients.
• Patients with known history of allergy to one of study drugs
• Patients with nerve conduction pathway injury.
• Severe circulatory or respiratory disease.
• Cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent
• Patients with history of Myasthenia gravis, epilepsy , history of pacemaker implantation .
• Patients who need to be awakened during the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Propofol-Fentanyl); Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.	Drug: Propofol-Fentanyl; Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.
Experimental: Group B (Propofol-Fentanyl-Dexmedetomidine); Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. In addition patients will receive Dexmedetomidine (0.5ug.kg) loading dose infused over 10 mins followed by a constant infusion rate of (0.2ug/kg/hr). Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.	Drug: Propofol-Fentanyl-Dexmedetomidine; Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. In addition patients will receive Dexmedetomidine (0.5ug.kg) loading dose infused over 10 mins followed by a constant infusion rate of (0.2ug/kg/hr). Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.
Experimental: Group C (Propofol-Fentanyl-Sevoflurane); Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. In addition the anesthesia will be maintained with inhalational anesthesia of 50% oxygen , 50% air plus sevoflurane concentration adjusted to keep BIS between 40 & 50 . Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation	Drug: Propofol-Fentanyl-Sevoflurane; Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. In addition the anesthesia will be maintained with inhalational anesthesia of 50% oxygen , 50% air plus sevoflurane concentration adjusted to keep BIS between 40 & 50 . Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amplitude score of Somato sensory evoked potential	The amplitude score of the waveforms will be measured. More than 50% decrease in the amplitude and more than 10% prolongation of the latency of Compound muscle action potential ( CMAP) from the baseline values will be defined as significant	6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The latency of Somato sensory evoked potential	The latency of the waveforms will be measured. More than 50% decrease in the amplitude and more than 10% prolongation of the latency of Compound muscle action potential (CMAP) from the baseline values will be defined as significant	6 hours postoperatively
The latency of motor evoked potential	The latency of the waveforms will be measured. More than 50% decrease in the amplitude and more than 10% prolongation of the latency of Compound muscle action potential (CMAP) from the baseline values will be defined as significant	6 hours postoperatively
The amplitude score of motor evoked potential	The amplitude of the waveforms will be measured. More than 50% decrease in the amplitude and more than 10% prolongation of the latency of Compound muscle action potential (CMAP) from the baseline values will be defined as significant	6 hours postoperatively
Intraoperative fentanyl consumption	Fentanyl (1 ug/kg) will be used to induce anesthesia.	Intraoperatively
Intraoperative propofol consumption	Propofol (2mg/kg) will be used to induce anesthesia	Intraoperatively
Intraoperative dexmedetomidine consumption	Dexmedetomidine (0.5ug/kg) loading dose infused over 10 mins followed by a constant infusion rate of (0.2ug/kg/hr)	Intraoperatively
Intraoperative sevoflurane consumption	the anesthesia will be maintained with inhalational anesthesia of 50% oxygen , 50% air plus sevoflurane concentration adjusted to keep BIS between 40 & 50	Intraoperatively
Changes in heart rate	Heart rate will be assessed immediately before the operation and every 10 minutes in the first 30 minutes of the operation then every 15 minutes till the end of the operation.	Till the end of operation
Changes in mean arterial pressure	Mean arterial pressure will be assessed immediately before the operation and every 10 minutes in the first 30 minutes of the operation then every 15 minutes till the end of operation	Till the end of operation
Quality of surgical field	Quality of surgical field will be evaluated every 15 minutes using the surgical field rating (SFR) scale of six points : 5 - massive uncontrollable bleeding, 4 - heavy but controllable bleeding that significantly interfered with dissection, 3 - moderate bleeding that moderately compromised surgical dissection, 2 - moderate bleeding - a nuisance but without interference with accurate dissection, 1 - bleeding, so mild it was not even a surgical nuisance, 0 - no bleeding and virtually bloodless field. Surgical field was graded as good, fair, and poor as: good - SFR scale 0 or 1, fair - SFR scale 2or 3, poor - SFR scale 4 or 5).	Till the end of operation
Intraoperative bleeding	Intraoperative bleeding will be measured by collecting blood in a marked container of 2500 ml capacity and the blood soaked by gauze pieces [4×4 soaked gauze piece (15 ml blood), completely soaked abdominal towel (150 ml blood)]	Intraoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Fentanyl; Propofol; Dexmedetomidine; Sevoflurane
• Other Study ID Numbers: FMASU MD206/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No