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

Ain Shams University

Status: Completed

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

Treatments: Drug: Propofol-Fentanyl; Drug: Propofol-Fentanyl-Dexmedetomidine; Drug: Propofol-Fentanyl-Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT06210061

FMASU MD206/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Group A (Propofol-Fentanyl)

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol-Fentanyl

Group B (Propofol-Fentanyl-Dexmedetomidine)

Experimental group

Description:

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.

Treatment:

Drug: Propofol-Fentanyl-Dexmedetomidine

Group C (Propofol-Fentanyl-Sevoflurane)

Experimental group

Description:

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

Treatment:

Drug: Propofol-Fentanyl-Sevoflurane