PropofolNCT06210061
Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
A study testing Propofol-Fentanyl, Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane in people with Propofol and Fentanyl, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Propofol, Fentanyl, Dexmedetomidine
- What is being tested?
- Propofol-Fentanyl, Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 1 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 21-45 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II and III.
- Undergoing major spine surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Propofol, Fentanyl, Dexmedetomidine, Sevoflurane, Spine Surgery, Somatosensory Evoked Potential
- Being tested
- Propofol-Fentanyl, Propofol-Fentanyl-Dexmedetomidine, Propofol-Fentanyl-Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol-FentanylDrug
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-DexmedetomidineDrug
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-SevofluraneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: Propofol-Fentanyl-Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours postoperatively
Secondary outcomes (11)
The latency of Somato sensory evoked potential
The latency 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
Measured: 6 hours postoperatively
The latency of motor evoked potential
The latency 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
Measured: 6 hours postoperatively
The amplitude score of motor evoked potential
The amplitude 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
Measured: 6 hours postoperatively
Intraoperative fentanyl consumption
Fentanyl (1 ug/kg) will be used to induce anesthesia.
Measured: Intraoperatively
Intraoperative propofol consumption
Propofol (2mg/kg) will be used to induce anesthesia
Measured: Intraoperatively
Intraoperative dexmedetomidine consumption
Dexmedetomidine (0.5ug/kg) loading dose infused over 10 mins followed by a constant infusion rate of (0.2ug/kg/hr)
Measured: Intraoperatively
Intraoperative sevoflurane consumption
the anesthesia will be maintained with inhalational anesthesia of 50% oxygen , 50% air plus sevoflurane concentration adjusted to keep BIS between 40 \& 50
Measured: Intraoperatively
Changes in heart rate
Heart rate will be assessed immediately before the operation and every 10 minutes in the first 30 minutes of the operation then every 15 minutes till the end of the operation.
Measured: Till the end of operation
Changes in mean arterial pressure
Mean arterial pressure will be assessed immediately before the operation and every 10 minutes in the first 30 minutes of the operation then every 15 minutes till the end of operation
Measured: Till the end of operation
Quality of surgical field
Quality of surgical field will be evaluated every 15 minutes using the surgical field rating (SFR) scale of six points : 5 - massive uncontrollable bleeding, 4 - heavy but controllable bleeding that significantly interfered with dissection, 3 - moderate bleeding that moderately compromised surgical dissection, 2 - moderate bleeding - a nuisance but without interference with accurate dissection, 1 - bleeding, so mild it was not even a surgical nuisance, 0 - no bleeding and virtually bloodless field. Surgical field was graded as good, fair, and poor as: good - SFR scale 0 or 1, fair - SFR scale 2or 3, poor - SFR scale 4 or 5).
Measured: Till the end of operation
Intraoperative bleeding
Intraoperative bleeding will be measured by collecting blood in a marked container of 2500 ml capacity and the blood soaked by gauze pieces [4×4 soaked gauze piece (15 ml blood), completely soaked abdominal towel (150 ml blood)]
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim ElSayed Shahin, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210061
- Sponsor's protocol ID
- FMASU MD206/2023
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.