Opioid Free VS Opioid Anesthesia for Craniotomies

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 5, 2021

Primary Completion Date

October 3, 2021

Study Completion Date

October 3, 2021

Conditions
Supratentorial Neoplasms
Interventions
DRUG

Opioid free anesthetics

"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"

DRUG

Opioid Anesthetics

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.

Trial Locations (1)

11687

Kasr El Aini Hospital, Cairo

All Listed Sponsors
lead

Kasr El Aini Hospital

OTHER