Health TrialsbyHealthPanel

Total Intravenous Anesthesia in Patients Undergoing Craniotomy

ConditionAnesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Dexmedetomidine as an adjunct to total intravenous anesthesia.

  • Fentanyl

    Drug

    Fentanyl as an adjunct to total intravenous anesthesia.

  • Magnesium

    Drug

    Magnesium sulphate as an adjunct to total intravenous anesthesia.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Dexmedetomidine groupActive comparator 1 intervention
Group B: Fentanyl groupActive comparator 1 intervention
Group C: Magnesium groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The total intraoperative propofol consumption

The total intraoperative propofol consumption (in milligrams).

Time frame
4 hours

Secondary outcomes

1

Intraoperative heart rate

Monitoring the changes in heart rate intraoperative.

Time frame
4 hours
2

Intraoperative mean arterial pressure

Monitoring the changes in mean arterial pressure intraoperative.

Time frame
4 hours
3

Brain relaxation score

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).

Time frame
4 hours
4

Additional doses of intraoperative fentanyl.

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

Time frame
4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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