Skip to main content
OpenTrials
Completed

NCT Number: NCT03722940

Role of Magnesium in Pediatric Cochlear Implant

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II children

Exclusion criteria

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

Treatment and study plan

Magnesium sulphate

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.

Other names: MGSO4

Na CL 0.9%

Other

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

Primary outcomes

  1. Quality of surgical field

    Time frame: at the end of the surgey

    using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal

Secondary outcomes

  1. The operative time

    Time frame: Intraoperative

    Minutes

  2. The anesthesia time.

    Time frame: Intraoperative

    Minutes

  3. ESRT responses

    Time frame: 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

  4. Heart rate

    Time frame: baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.

    beats per minute

  5. Mean arterial blood pressure

    Time frame: Intraoperative

    mm Hg

  6. Anesthetic consumption

    Time frame: Intraoperative

    propofol and fentanyl requirement after the bolus

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • Bahteem Specialized Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 29, 2018
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.