At a glance
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Hemodynamic Effects of Opioid Free Anesthesia Versus Opioid Anesthesia on Adult Patients Undergoing Craniotomies for Supratentorial Tumors. Randomized Controlled Trial
In Brief
A Phase 1 clinical trial evaluating Opioid free anesthetics and Opioid Anesthetics for Supratentorial Neoplasms. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients will receive over the 10 minutes prior to induction: * Acetaminophen 1 gm i.v. infusion in 100ml over 10 minutes. * Ketorolac 30 mg i.v. infusion in100 ml over 10 minutes. * Mg SO4 loading dose 30 mg/kg i.v. infusion in 100 ml over 10 minutes. * Dexmedetomidine loading dose 1 μg/kg i.v. infusion. * Lidocaine loading dose 1.5 mg/kg i.v. infusion. * Ketamine loading dose 0.25 mg/kg i.v. infusion. The weight based doses of dexmedetomidine, lidocaine, ketamine will be prepared on 20 ml syringe and infused over 10 minutes prior to induction. In a dose of 0.1 ml/kg Then after induction maintenance analgesic infusion will start in a rate that ranges from 0.025 to 0.05 ml/kg/h which is equivalent to: * Dexmedetomidine 0.25-0.5 μg/kg/h * Lidocaine 0.375-0.75 mg/kg/h * Ketamine 0.0625- 0.125 mg/kg/h
Placebo equivalent to acetaminophen, ketorolac, magnesium sulphate will be infused as 100 ml normal saline each over 10 minutes ,patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h.