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Opioid Free VS Opioid Anesthesia for Craniotomies

NCT04941040 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-19

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Rania S Fahmy · Kasr Al Ainy, Faculty of medicine, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2021-10-03
Completion
2021-10-03

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941040 on ClinicalTrials.gov