Role of Magnesium in Pediatric Cochlear Implant

Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Magnesium sulphate; Other: Na CL 0.9%

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I and II children

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium sulphate; Group M	Drug: Magnesium 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.; Other Names: MGSO4
Placebo Comparator: Na CL 0.9%; group C	Other: Na 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.; Other Names: isotonic saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of surgical field	using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal	at the end of the surgey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The operative time	Minutes	Intraoperative
The anesthesia time.	Minutes	Intraoperative
ESRT responses	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	After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),
Heart rate	beats per minute	baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.
Mean arterial blood pressure	mm Hg	Intraoperative
Anesthetic consumption	propofol and fentanyl requirement after the bolus	Intraoperative

Collaborators and Investigators

• Sponsor: Wahba bakhet
• Collaborators: Bahteem Specialized Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: Bahtem WBAKHET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No