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OpenTrials
Active, not recruiting

NCT Number: NCT07105618

Total Intravenous Anesthesia in Patients Undergoing Craniotomy

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anesthesia

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospital

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine as an adjunct to total intravenous anesthesia.

Other names: Precedex

Fentanyl

Drug

Fentanyl as an adjunct to total intravenous anesthesia.

Magnesium

Drug

Magnesium sulphate as an adjunct to total intravenous anesthesia.

Other names: Magnesium sulphate

Primary outcomes

  1. The total intraoperative propofol consumption

    Time frame: 4 hours

    The total intraoperative propofol consumption (in milligrams).

Secondary outcomes

  1. Intraoperative heart rate

    Time frame: 4 hours

    Monitoring the changes in heart rate intraoperative.

  2. Intraoperative mean arterial pressure

    Time frame: 4 hours

    Monitoring the changes in mean arterial pressure intraoperative.

  3. Brain relaxation score

    Time frame: 4 hours

    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).

  4. Additional doses of intraoperative fentanyl.

    Time frame: 4 hours

    The total number of patients requiring additional dose of intraoperative fentanyl.

  5. The time to first request for rescue analgesia

    Time frame: The first 24 hours postoperative.

    The time to first request for rescue analgesia in first 24 hour.

  6. Postoperative pain assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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