drugset / Trial / NCT04941040
Opioid Free VS Opioid Anesthesia for Craniotomies
RandomizedParallel-groupTriple-blindPrevention
Summary
Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.
Timeline
- Start
- 2021-07-05
- Primary completion
- 2021-10-03
- Completion
- 2021-10-03
Publications
- Background Uyar AS, Yagmurdur H, Fidan Y, Topkaya C, Basar H. Dexmedetomidine attenuates the hemodynamic and neuroendocrinal responses to skull-pin head-holder application during craniotomy. J Neurosurg Anesthesiol. 2008 Jul;20(3):174-9. doi: 10.1097/ANA.0b013e318177e5eb.
- Background Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
- Background Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
- Background Mulier JP. Perioperative opioids aggravate obstructive breathing in sleep apnea syndrome: mechanisms and alternative anesthesia strategies. Curr Opin Anaesthesiol. 2016 Feb;29(1):129-33. doi: 10.1097/ACO.0000000000000281.
- Background Cortinez LI, Hsu YW, Sum-Ping ST, Young C, Keifer JC, Macleod D, Robertson KM, Wright DR, Moretti EW, Somma J. Dexmedetomidine pharmacodynamics: Part II: Crossover comparison of the analgesic effect of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1077-83. doi: 10.1097/00000542-200411000-00006.
- Background Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
- Background Syeda S, Palaniswamy SR, Sriganesh K. Opioid Free Analgesia With Dexmedetomidine for Craniotomy in an Obese Patient With Obstructive Sleep Apnea and Difficult Airway. Asian J Anesthesiol. 2020 Jun 1;58(2):76-77. doi: 10.6859/aja.202006_58(2).0007. Epub 2020 Jul 24. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1 g | Intravenous |
| Subject | Dexmedetomidine | Other / unclassified | 0.25 ug/kg | Intravenous |
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 0.5 ug/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 1 ug/kg | Intravenous |
| Subject | Ketamine | Small molecule | 0.0625 mg/kg | Intravenous |
| Subject | Ketamine | Small molecule | 0.125 mg/kg | Intravenous |
| Subject | Ketorolac | Other / unclassified | 30 mg | Intravenous |
| Subject | Lidocaine | Other / unclassified | 0.375 mg/kg | Intravenous |
| Subject | Lidocaine | Other / unclassified | 0.75 mg/kg | Intravenous |
| Subject | Magnesium Sulfate | Other / unclassified | 30 mg/kg | Intravenous |