Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
NCT ID: NCT04535089
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2020-10-01
2021-10-01
Brief Summary
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Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.
Detailed Description
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This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals.
b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dexmedetomdine
IV bolus dose of 0.5ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5ug/kg/h
Dexmedetomidine injection
receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h
lidocaine
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Lidocaine Iv
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Interventions
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Dexmedetomidine injection
receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h
Lidocaine Iv
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sex: both sexes.
* Physical status: American Society Of Anesthesiologist 1\& II.
* Body Mass Index \>5 th and \< the 85th percentile for age.
* Type of operations: elective intracranial surgeries under general anesthesia.
* Duration of operation \< 3 hours.
* Written informed consent from the parent of child
Exclusion Criteria
* Unsuitability for extubation.
* Patients on beta blocker, alpha 2 agonist.
* Patients on pain killer or with known history of allergy to study drugs.
* Hepatic, renal, Cardiovascular and respiratory disease.
* The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
6 Years
18 Years
ALL
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Alshaimaa Abdel Fattah Kamel
lecturer of Anaesthesia ,and surgical intensive care
Principal Investigators
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Alshaimaa Kamel, M.D
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Locations
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Zagazig University, Faculty of medicine
Zagazig, , Egypt
Countries
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Other Identifiers
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6318
Identifier Type: -
Identifier Source: org_study_id