Role of Magnesium in Pediatric Cochlear Implant

Wahba bakhet

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Other: Na CL 0.9%; Drug: Magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03722940

Bahtem WBAKHET

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I and II children

Exclusion criteria

• uncontrolled hypertension,
• diabetes mellitus,
• liver disease,
• kidney disease,
• heart disease,
• allergy to magnesium sulphate,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Magnesium sulphate

Active Comparator group

Description:

Group M

Treatment:

Drug: Magnesium sulphate

Na CL 0.9%

Placebo Comparator group

Description:

group C

Treatment:

Other: Na CL 0.9%