drugset / Trial / NCT03548493
Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.
Timeline
- Start
- 2018-04-10
- Primary completion
- 2018-08-08
- Completion
- 2018-08-09
Publications
- Background Guzel A, Kaya S, Ozkan U, Ufuk Aluclu M, Ceviz A, Belen D. Surgical treatment of chronic subdural haematoma under monitored anaesthesia care. Swiss Med Wkly. 2008 Jul 12;138(27-28):398-403. doi: 10.4414/smw.2008.12121.
- Background Bishnoi V, Kumar B, Bhagat H, Salunke P, Bishnoi S. Comparison of Dexmedetomidine Versus Midazolam-Fentanyl Combination for Monitored Anesthesia Care During Burr-Hole Surgery for Chronic Subdural Hematoma. J Neurosurg Anesthesiol. 2016 Apr;28(2):141-6. doi: 10.1097/ANA.0000000000000194.
- Background Sato M, Shirakami G, Fukuda K. Comparison of general anesthesia and monitored anesthesia care in patients undergoing breast cancer surgery using a combination of ultrasound-guided thoracic paravertebral block and local infiltration anesthesia: a retrospective study. J Anesth. 2016 Apr;30(2):244-51. doi: 10.1007/s00540-015-2111-z. Epub 2015 Dec 10.
- Background Drown MB. Integrative review utilizing dexmedetomidine as an anesthetic for monitored anesthesia care and regional anesthesia. Nurs Forum. 2011 Jul-Sep;46(3):186-94. doi: 10.1111/j.1744-6198.2011.00229.x.
- Background David H, Shipp J. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. Ann Emerg Med. 2011 May;57(5):435-41. doi: 10.1016/j.annemergmed.2010.11.025. Epub 2011 Jan 21.
- Background Wang W, Feng L, Bai F, Zhang Z, Zhao Y, Ren C. The Safety and Efficacy of Dexmedetomidine vs. Sufentanil in Monitored Anesthesia Care during Burr-Hole Surgery for Chronic Subdural Hematoma: A Retrospective Clinical Trial. Front Pharmacol. 2016 Nov 3;7:410. doi: 10.3389/fphar.2016.00410. eCollection 2016.
- Background Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.
- Background Cizmeci P, Ozkose Z. Magnesium sulphate as an adjuvant to total intravenous anesthesia in septorhinoplasty: a randomized controlled study. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):167-73. doi: 10.1007/s00266-006-0194-5.
- Background Prontera A, Baroni S, Marudi A, Valzania F, Feletti A, Benuzzi F, Bertellini E, Pavesi G. Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil. Drug Des Devel Ther. 2017 Mar 3;11:593-598. doi: 10.2147/DDDT.S124736. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 0.5 ug/kg | Intravenous |
| Subject | Magnesium Sulfate | Other / unclassified | 15 mg/kg | Intravenous |
| Background | Propofol | Small molecule | 20 ug/kg | Intravenous |
| Background | Propofol | Small molecule | 40 ug/kg | Intravenous |
Indications
No indication recorded.