Role of Magnesium in Pediatric Cochlear Implant

NCT ID: NCT03722940

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Magnesium sulphate

Group M

Group Type ACTIVE_COMPARATOR

Magnesium sulphate

Intervention Type DRUG

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.

Na CL 0.9%

group C

Group Type PLACEBO_COMPARATOR

Na CL 0.9%

Intervention Type OTHER

Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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MGSO4 isotonic saline solution

Eligibility Criteria

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Inclusion Criteria

* ASA I and II children

Exclusion Criteria

* uncontrolled hypertension,
* diabetes mellitus,
* liver disease,
* kidney disease,
* heart disease,
* allergy to magnesium sulphate,
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahteem Specialized Hospital

OTHER

Sponsor Role collaborator

Wahba bakhet

OTHER

Sponsor Role lead

Responsible Party

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Wahba bakhet

Lectrure of anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Bahtem WBAKHET

Identifier Type: -

Identifier Source: org_study_id

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