Clinical trial

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

Name

FMASU MD206/2023

Description

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

Trial arms

Trial start

2023-09-01

Estimated PCD

2024-09-01

Trial end

2024-09-01

Status

Recruiting

Treatment

Propofol-Fentanyl

Arms:

Group A (Propofol-Fentanyl)

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.

Arms:

Group B (Propofol-Fentanyl-Dexmedetomidine)

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

Arms:

Group C (Propofol-Fentanyl-Sevoflurane)

Size

Primary endpoint

The amplitude score of Somato sensory evoked potential

6 hours postoperatively

Eligibility criteria

Inclusion Criteria: * Age from 21-45 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I and II. * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}

Updated at

2024-01-18

1 organization

3 products

7 indications

Organization

Ain Shams University

Product

Propofol-Fentanyl

Indication

Propofol

Indication