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Recruiting NCT07105618

Total Intravenous Anesthesia in Patients Undergoing Craniotomy

No phase Interventional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, Fentanyl, Magnesium.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Dexmedetomidine
    Dexmedetomidine as an adjunct to total intravenous anesthesia.
  • Drug Fentanyl
    Fentanyl as an adjunct to total intravenous anesthesia.
  • Drug Magnesium
    Magnesium sulphate as an adjunct to total intravenous anesthesia.

Primary outcome measures

  • The total intraoperative propofol consumption [Time frame: 4 hours]
Secondary outcome measures (6)
  • Intraoperative heart rate [Time frame: 4 hours]
  • Intraoperative mean arterial pressure [Time frame: 4 hours]
  • Brain relaxation score [Time frame: 4 hours]
  • Additional doses of intraoperative fentanyl. [Time frame: 4 hours]
  • The time to first request for rescue analgesia [Time frame: The first 24 hours postoperative.]
  • Postoperative pain assessment [Time frame: The first 24 hours postoperative.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Zagazig university hospital — Zagazig

Publications

  • 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
  • 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
  • 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 eme PMID 39777171
  • 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. Epu PMID 31664468

Identifiers

NCT: NCT07105618 · Craniotomy anesthesia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗