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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine as an adjunct to total intravenous anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total intraoperative propofol consumption | The total intraoperative propofol consumption (in milligrams). | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative heart rate | Monitoring the changes in heart rate intraoperative. | 4 hours |
| Intraoperative mean arterial pressure | Monitoring the changes in mean arterial pressure intraoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherif Mohammed Said Mowafy, MD | Contact | 01003523374 | sherifmowafy2012@gmail.com | |
| Mohamed gaber, MD | Contact | mgmelsayed@medicine.zu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Mahmoud Ahmed, MD | Department of Anesthesia, Intensive Care & Pain Management, Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig university hospital | Recruiting | Zagazig | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20805754 | Background | 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. | |
| 12393361 | 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. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| D008274 | Magnesium |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | Fentanyl as an adjunct to total intravenous anesthesia. |
|
| Magnesium | Drug | Magnesium sulphate as an adjunct to total intravenous anesthesia. |
|
|
| 4 hours |
| 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). | 4 hours |
| Additional doses of intraoperative fentanyl. | The total number of patients requiring additional dose of intraoperative fentanyl. | 4 hours |
| The time to first request for rescue analgesia | The time to first request for rescue analgesia in first 24 hour. | The first 24 hours postoperative. |
| Postoperative pain assessment | Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery. | The first 24 hours postoperative. |
| 39777171 | 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. |
| 31664468 | 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. |
| D010880 |
| Piperidines |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |