Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
NCT ID: NCT06210061
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2024-01-20
2025-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
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.
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
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
Interventions
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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.
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.
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
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II and III.
* Undergoing major spine surgery
Exclusion Criteria
* 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.
21 Years
45 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed Ibrahim ElSayed Shahin
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU MD206/2023
Identifier Type: -
Identifier Source: org_study_id