Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine as an adjunct to total intravenous anesthesia.

Fentanyl group

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.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Fentanyl as an adjunct to total intravenous anesthesia.

Magnesium group

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.

Group Type ACTIVE_COMPARATOR

Magnesium

Intervention Type DRUG

Magnesium sulphate as an adjunct to total intravenous anesthesia.

Interventions

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Dexmedetomidine

Dexmedetomidine as an adjunct to total intravenous anesthesia.

Intervention Type DRUG

Fentanyl

Fentanyl as an adjunct to total intravenous anesthesia.

Intervention Type DRUG

Magnesium

Magnesium sulphate as an adjunct to total intravenous anesthesia.

Intervention Type DRUG

Other Intervention Names

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Precedex Magnesium sulphate

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No