Anesthesia
Conditions
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
Interventions
DRUGMagnesium sulphate
Before induction of anesthesia; children in group M received an iv bolus dose of magnesium sulfate (Magnesium sulfate ampoule 1 gm/10 ml, Eipico, Egypt) 40 mg Kg-1 over 5 minutes followed by 15 mg Kg-1 h-1 ivi until the start of skin closure.
OTHERNa CL 0.9%
Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate.
Sponsors
Bahteem Specialized Hospital
Wahba bakhet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* ASA I and II children
Exclusion criteria
* uncontrolled hypertension, * diabetes mellitus, * liver disease, * kidney disease, * heart disease, * allergy to magnesium sulphate,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The anesthesia 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 |
| The operative time | Intraoperative | Minutes |
| Mean arterial blood pressure | Intraoperative | mm Hg |
| Anesthetic consumption | Intraoperative | propofol and fentanyl requirement after the bolus |
| Heart rate | baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission. | beats per minute |
Outcome results
None listed