Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Zagazig University

Status: Enrolling

Conditions: Anesthesia

Treatments: Drug: Magnesium; Drug: Fentanyl; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07105618

Craniotomy anesthesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Fentanyl group

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

Magnesium group

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium