Total intravenous anesthesia with dexmedetomidine, fentanyl, or magnesium for craniotomy
Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy
This trial will test whether adding dexmedetomidine, fentanyl, or magnesium to propofol-based total intravenous anesthesia helps people having elective craniotomy recover faster, keep stable blood pressure and brain relaxation, and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT07105618 on ClinicalTrials.gov |
What this trial studies
Researchers at Zagazig University Hospital will compare dexmedetomidine, fentanyl, and magnesium as adjuncts to propofol-based total intravenous anesthesia in adults undergoing elective craniotomy for tumor resection. Eligible patients are ASA physical status 1–2 with BMI ≤30 kg/m2 and anticipated surgery duration within four hours. The trial will monitor intraoperative hemodynamics, quality of brain relaxation, emergence time, analgesia requirements, and postoperative complications and length of hospital stay. Safety and efficacy profiles of each adjunct will be compared to identify the optimal TIVA adjunct for these neurosurgical patients.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective craniotomy for brain tumor resection who are ASA 1–2, have BMI ≤30 kg/m2, expect surgery under four hours, and do not have major organ dysfunction or chronic opioid use.
Not a fit: Patients with hemodynamic instability, anticipated postoperative mechanical ventilation, advanced hepatic, renal, cardiovascular, or neurologic disease, known allergy to study drugs, or chronic opioid use are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the approach could shorten recovery time, improve intraoperative stability and brain relaxation, reduce pain and complications, and shorten hospital stay.
How similar studies have performed: Propofol-based TIVA with dexmedetomidine or opioids has prior evidence for stable hemodynamics and rapid emergence in neurosurgery, while magnesium as an adjunct is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient acceptance. * Physical status: American Society of Anesthesiologists Physical Status (ASA) 1\& II. * Body mass index ≤ 30 kg/m2. * Type of operation: elective craniotomy for brain tumor resection. * Duration of surgery: within 4 hours. Exclusion Criteria: * Patient with hemodynamic instability or anticipated postoperative mechanical ventilation. * Patients with a known history of allergy to the study drugs. * Advanced hepatic, renal, cardiovascular, and neurologic diseases. * Patients with chronic opioid use.
Where this trial is running
Zagazig
- Zagazig university hospital — Zagazig, Egypt (Recruiting)
Study contacts
- Principal investigator: Fatma Mahmoud Ahmed, MD — Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
- Study coordinator: Sherif Mohammed Said Mowafy, MD
- Email: sherifmowafy2012@gmail.com
- Phone: 01003523374
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.