Role of Magnesium in Pediatric Cochlear Implant
- Registration Number
- NCT03722940
- Lead Sponsor
- Wahba bakhet
- Brief Summary
To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery. Also its effects on the intraoperative evoked stapedial reflex thresholds (ESRT) and the intraoperative anesthetic requirements were evaluated.
- Detailed Description
Sixty-six ASA I and II children (1-6 years) undergoing cochlear implantation under general anesthesia were enrolled in this double blind, randomized study. Children were randomly allocated into two equal groups. Children in Group M (magnesium sulphate group) received an iv bolus dose of magnesium sulfate 40 mg Kg-1 over 5 minutes before induction of anesthesia followed by 15mg Kg-1 h-1 infusion until the start of skin closure. Children in Group C (Control group) received equivalent volumes of isotonic saline solution over the same period instead of magnesium sulphate. Haemodynamic variables, quality of surgical field, ESRT and the intraoperative anesthetic requirements were recorded
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- ASA I and II children
- uncontrolled hypertension,
- diabetes mellitus,
- liver disease,
- kidney disease,
- heart disease,
- allergy to magnesium sulphate,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium sulphate Magnesium sulphate Group M Na CL 0.9% Na CL 0.9% group C
- Primary Outcome Measures
Name Time Method Quality of surgical field at the end of the surgey using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal
- Secondary Outcome Measures
Name Time Method The operative time Intraoperative Minutes
ESRT responses After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9), the surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct microscopic examination
Heart rate baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission. beats per minute
The anesthesia time. Intraoperative Minutes
Mean arterial blood pressure Intraoperative mm Hg
Anesthetic consumption Intraoperative propofol and fentanyl requirement after the bolus