Total Intravenous Anesthesia in Patients Undergoing Craniotomy

NCT07105618 | Recruiting

• 1 other identifier: Craniotomy anesthesia
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The total intraoperative propofol consumption

  The total intraoperative propofol consumption (in milligrams).

  4 hours

Secondary Outcomes (6)

• Intraoperative heart rate

  4 hours

• Intraoperative mean arterial pressure

  4 hours

• Brain relaxation score

  4 hours

• Additional doses of intraoperative fentanyl.

  4 hours

• The time to first request for rescue analgesia

  The first 24 hours postoperative.

Study Arms (3)

Dexmedetomidine group

ACTIVE COMPARATOR

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

Fentanyl group

ACTIVE COMPARATOR

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 group

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

Dexmedetomidine as an adjunct to total intravenous anesthesia.

Also known as: Precedex

Dexmedetomidine group

Fentanyl DRUG

Fentanyl as an adjunct to total intravenous anesthesia.

Fentanyl group

Magnesium DRUG

Magnesium sulphate as an adjunct to total intravenous anesthesia.

Also known as: Magnesium sulphate

Magnesium group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospital

Zagazig, Egypt

RECRUITING

Related Publications (4)

• Ali AR, El Ghoneimy MN. Dexmedetomidine versus fentanyl as adjuvant to propofol: comparative study in children undergoing extracorporeal shock wave lithotripsy. Eur J Anaesthesiol. 2010 Dec;27(12):1058-64. doi: 10.1097/EJA.0b013e32833e6e2d.

  PMID: 20805754 BACKGROUND

• Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.

  PMID: 12393361 BACKGROUND

• Chandar Chinnarasan V, Bidkar PU, Swaminathan S, Mani M, Vairappan B, Chatterjee P, Joy JJ, Dey A, Ramadurai R, Gunasekaran A. Comparison of dexmedetomidine versus fentanyl-based total intravenous anesthesia technique on the requirement of propofol, brain relaxation, intracranial pressure, neuronal injury, and hemodynamic parameters in patients with acute traumatic subdural hematoma undergoing emergency craniotomy: A randomized controlled trial. Surg Neurol Int. 2024 Dec 13;15:462. doi: 10.25259/SNI_892_2024. eCollection 2024.

  PMID: 39777171 BACKGROUND

• Preethi J, Bidkar PU, Cherian A, Dey A, Srinivasan S, Adinarayanan S, Ramesh AS. Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial. Eur J Trauma Emerg Surg. 2021 Jun;47(3):831-837. doi: 10.1007/s00068-019-01249-4. Epub 2019 Oct 29.

  PMID: 31664468 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl; Magnesium; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Fatma Mahmoud Ahmed, MD

  Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif Mohammed Said Mowafy, MD

CONTACT

01003523374; sherifmowafy2012@gmail.com

Mohamed gaber, MD

CONTACT

mgmelsayed@medicine.zu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 6, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-06

Locations

EG (1)