NCT03722940

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 19, 2018

Last Update Submit

October 25, 2019

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The operative time

    Intraoperative

  • The anesthesia time.

    Intraoperative

  • ESRT responses

    After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),

  • Heart rate

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

  • Mean arterial blood pressure

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

Magnesium sulphate

ACTIVE COMPARATOR

Group M

Drug: Magnesium sulphate

Na CL 0.9%

PLACEBO COMPARATOR

group C

Other: Na CL 0.9%

Interventions

Magnesium sulphateDRUG

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.

Also known as: MGSO4
Magnesium sulphate
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.

Also known as: isotonic saline solution
Na CL 0.9%

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lectrure of anesthesia

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 29, 2018

Study Start

June 1, 2014

Primary Completion

May 30, 2017

Study Completion

August 1, 2018

Last Updated

October 29, 2019

Record last verified: 2019-10