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

NCT06210061 | Completed

• 1 other identifier: FMASU MD206/2023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Somatosensory Evoked Potential; Motor Evoked Potential; Propofol; Fentanyl; Dexmedetomidine; Sevoflurane; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The latency of Somato sensory evoked potential

  6 hours postoperatively

• The latency of motor evoked potential

  6 hours postoperatively

• The amplitude score of motor evoked potential

  6 hours postoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

• Intraoperative propofol consumption

  Intraoperatively

Study Arms (3)

Group A (Propofol-Fentanyl)

ACTIVE COMPARATOR

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

Group B (Propofol-Fentanyl-Dexmedetomidine)

EXPERIMENTAL

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

Group C (Propofol-Fentanyl-Sevoflurane)

EXPERIMENTAL

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

Interventions

Propofol-Fentanyl DRUG

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.

Group A (Propofol-Fentanyl)

Propofol-Fentanyl-Dexmedetomidine DRUG

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.

Group B (Propofol-Fentanyl-Dexmedetomidine)

Propofol-Fentanyl-Sevoflurane DRUG

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

Group C (Propofol-Fentanyl-Sevoflurane)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 18, 2024
• Study Start: January 20, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)