Anesthesia
Conditions
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.
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
DRUGDexmedetomidine
Dexmedetomidine as an adjunct to total intravenous anesthesia.
DRUGFentanyl
Fentanyl as an adjunct to total intravenous anesthesia.
DRUGMagnesium
Magnesium sulphate as an adjunct to total intravenous anesthesia.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total intraoperative propofol consumption | 4 hours | The total intraoperative propofol consumption (in milligrams). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative heart rate | 4 hours | Monitoring the changes in heart rate intraoperative. |
| Intraoperative mean arterial pressure | 4 hours | Monitoring the changes in mean arterial pressure intraoperative. |
| Brain relaxation score | 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). |
| Additional doses of intraoperative fentanyl. | 4 hours | The total number of patients requiring additional dose of intraoperative fentanyl. |
| The time to first request for rescue analgesia | The first 24 hours postoperative. | The time to first request for rescue analgesia in first 24 hour. |
| Postoperative pain assessment | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORFatma Mahmoud Ahmed, MD
Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
Outcome results
None listed