Trials / Completed
CompletedNCT03722940
Role of Magnesium in Pediatric Cochlear Implant
Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Wahba bakhet · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2017-05-30
- Completion
- 2018-08-01
- First posted
- 2018-10-29
- Last updated
- 2019-10-29
Source: ClinicalTrials.gov record NCT03722940. Inclusion in this directory is not an endorsement.