Evaluating anesthesia methods for major spine surgery
A Comparative Study of Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
NA · Ain Shams University · NCT06210061
This study is testing if adding a medication called dexmedetomidine to standard anesthesia during major spine surgery can help protect nerves and the spinal cord from injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06210061 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of adding dexmedetomidine to propofol and fentanyl anesthesia during major spine surgeries while monitoring somatosensory and motor evoked potentials. The research focuses on reducing the risk of nerve and spinal cord injuries, which can occur during such surgeries. By comparing total intravenous anesthesia with dexmedetomidine against traditional methods, the study seeks to determine the optimal anesthesia approach that minimizes neurological complications. The use of electrophysiological monitoring is crucial in this context to ensure patient safety and improve surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21-45 years undergoing major spine surgery with ASA physical status I and II.
Not a fit: Patients with severe circulatory or respiratory diseases, cognitive impairments, or those requiring awakening during the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of neurological defects during major spine surgeries.
How similar studies have performed: Other studies have indicated the potential benefits of combining intravenous and inhalational anesthesia in similar surgical contexts, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mohamed I Shahin, Master
- Email: mohamed.i.shahin@med.asu.edu.eg
- Phone: 00201024556447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Propofol, Fentanyl, Dexmedetomidine, Sevoflurane, Spine Surgery, Somatosensory Evoked Potential, Motor Evoked Potential