Role of Magnesium in Pediatric Cochlear Implant

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722940
• Other study ID #: Bahtem WBAKHET
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2014
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 1, 2018
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ASA I and II children

Exclusion Criteria:

• uncontrolled hypertension,

• diabetes mellitus,

• liver disease,

• kidney disease,

• heart disease,

• allergy to magnesium sulphate,

Related Conditions & MeSH terms

• Anesthesia

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	bahteem specialized hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The operative time	Minutes	Intraoperative
Secondary	The anesthesia time.	Minutes	Intraoperative
Secondary	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),
Secondary	Heart rate	beats per minute	baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.
Secondary	Mean arterial blood pressure	mm Hg	Intraoperative
Secondary	Anesthetic consumption	propofol and fentanyl requirement after the bolus	Intraoperative