Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Overview
- Phase
- Phase 1
- Intervention
- Dexmedetomidine injection
- Conditions
- Analgesia
- Sponsor
- Zagazig University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Intraoperative total fentanyl consumption.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future.
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
Site of study: 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.
Investigators
Alshaimaa Abdel Fattah Kamel
lecturer of Anaesthesia ,and surgical intensive care
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •Age: 6-18 years old.
- •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
- •Altered mental state
- •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.
Arms & Interventions
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
Intervention: Dexmedetomidine injection
lidocaine
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Intervention: Lidocaine Iv
Outcomes
Primary Outcomes
Intraoperative total fentanyl consumption.
Time Frame: from induction till end of surgery up to 3 hours intraoperative.
Intraoperative fentanyl 0.5ug/ kg when the heart rate and mean arterial blood pressure of patients increased \> 20% from basal measurement after exclusion of other causes.
Secondary Outcomes
- side-effects(up to 12 hour postoperative)
- pain intensity(immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.)
- Time to first call for rescue analgesic (fentanyl)(up to one hour postoperative)
- level of sedation(up to one hour postoperative)
- Total amount of nalbuphine consumption(up to twelve hours postoperative)
- The duration of Post Anesthesia Care Unite stay(up to 2 hour postoperative)