Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Not Applicable

Not yet recruiting

• Conditions: Anesthesia
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Magnesium

• Registration Number: NCT07105618
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-01
• Primary Completion: 2026-03
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	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.
Fentanyl group	Fentanyl	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.
Magnesium group	Magnesium	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.

Primary Outcome Measures

Name	Time	Method
The total intraoperative propofol consumption	4 hours	The total intraoperative propofol consumption (in milligrams).

Secondary Outcome Measures

Name	Time	Method
Intraoperative heart rate	4 hours	Monitoring the changes in heart rate intraoperative.
Intraoperative mean arterial pressure	4 hours	Monitoring the changes in mean arterial pressure intraoperative.
Additional doses of intraoperative fentanyl.	4 hours	The total number of patients requiring additional dose of intraoperative fentanyl.
The time to first request for rescue analgesia	The first 24 hours postoperative.	The time to first request for rescue analgesia in first 24 hour.
Postoperative pain assessment	The first 24 hours postoperative.	Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery.