An interventional study of Dexmedetomidine and Fentanyl in Anesthesia, sponsored by Zagazig University. Active, not recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications.
Total intravenous anesthesia, particularly with propofol-based regimens, has gained favor in neurosurgical procedures for its neuroprotective properties, and reduced intracranial pressure; however, the choice of adjunct agents in total intravenous anesthesia remains a subject of ongoing investigation, especially regarding their influence on hemodynamic stability, analgesia, brain relaxation, and postoperative outcomes.
Total intravenous anesthesia techniques for craniotomy allow rapid recovery and stable hemodynamic parameters, so they decrease the hospital stay. The current study will compare the efficacy and safety profiles of dexmedetomidine, fentanyl, and magnesium sulfate as adjuncts in total intravenous anesthesia for patients undergoing craniotomy.
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous loading dose of dexmedetomidine 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour.
Drug: Dexmedetomidine
Intravenous loading dose of fentanyl 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour.
Drug: Fentanyl
Magnesium sulphate 30-50 mg/kg intravenous over 15-30 minutes before propofol infusion, followed by intraoperative maintenance infusion of 10-20 mg/kg/hour.
Drug: Magnesium
Dexmedetomidine as an adjunct to total intravenous anesthesia.
Also known as: Precedex
Fentanyl as an adjunct to total intravenous anesthesia.
Magnesium sulphate as an adjunct to total intravenous anesthesia.
Also known as: Magnesium sulphate
The total intraoperative propofol consumption
The total intraoperative propofol consumption (in milligrams).
Time frame: 4 hours
Intraoperative heart rate
Monitoring the changes in heart rate intraoperative.
Time frame: 4 hours
Intraoperative mean arterial pressure
Monitoring the changes in mean arterial pressure intraoperative.
Time frame: 4 hours
Brain relaxation score
Evaluating the brain relaxation right after the dura is opened using a scale from 1 to 4 (1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain).
Time frame: 4 hours
Additional doses of intraoperative fentanyl.
The total number of patients requiring additional dose of intraoperative fentanyl.
Time frame: 4 hours
The time to first request for rescue analgesia
The time to first request for rescue analgesia in first 24 hour.
Time frame: The first 24 hours postoperative.
Postoperative pain assessment
Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery.
Time frame: The first 24 hours postoperative.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Zagazig University