Clinical trial NCT06210061: Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
Official title: A Comparative Study of Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Propofol
Fentanyl
Dexmedetomidine
Sevoflurane
Spine Surgery
Somatosensory Evoked Potential
Motor Evoked Potential
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

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.

Primary outcomes:
measure: The amplitude score of Somato sensory evoked potential
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: The latency of Somato sensory evoked potential
timeFrame: 6 hours postoperatively
measure: The latency of motor evoked potential
timeFrame: 6 hours postoperatively
measure: The amplitude score of motor evoked potential
timeFrame: 6 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Intraoperative propofol consumption
timeFrame: Intraoperatively
measure: Intraoperative dexmedetomidine consumption
timeFrame: Intraoperatively
measure: Intraoperative sevoflurane consumption
timeFrame: Intraoperatively
measure: Changes in heart rate
timeFrame: Till the end of operation
measure: Changes in mean arterial pressure
timeFrame: Till the end of operation
measure: Quality of surgical field
timeFrame: Till the end of operation
measure: Intraoperative bleeding
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: