AnesthesiaPhase 4NCT03722940
Role of Magnesium in Pediatric Cochlear Implant
A Phase 4 study testing Magnesium sulphate and Na CL 0.9% in people with Anesthesia, run by Wahba bakhet.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Magnesium sulphate and Na CL 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA I and II children
Who cannot join
- uncontrolled hypertension,
- diabetes mellitus,
- liver disease,
- kidney disease,
- heart disease,
- allergy to magnesium sulphate,
About this study
Official title: Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery
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.
Read the 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
- Anesthesia
- Being tested
- Magnesium sulphate, Na CL 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Also called MGSO4
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%Other
Also called isotonic saline solution
Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Active comparator | Group M Receives: Drug: Magnesium sulphate |
| Na CL 0.9% | Placebo comparator | group C Receives: Other: Na CL 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of surgical field
using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal
Measured: at the end of the surgey
Secondary outcomes (6)
The operative time
Minutes
Measured: Intraoperative
The anesthesia time.
Minutes
Measured: Intraoperative
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
Measured: After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),
Heart rate
beats per minute
Measured: baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.
Mean arterial blood pressure
mm Hg
Measured: Intraoperative
Anesthetic consumption
propofol and fentanyl requirement after the bolus
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Jun 2014
- Primary completion30 May 2017
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wahba bakhet
- Sponsor type
- University, hospital or other
- Collaborators
- Bahteem Specialized Hospital
- Responsible party
- Sponsor-investigator, Wahba bakhet, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722940
- Sponsor's protocol ID
- Bahtem WBAKHET
- Status last verified
- Oct 2019
- First submitted
- 19 Oct 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT03722940
- Acronym / sponsor ID
- Bahtem WBAKHET
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Wahba bakhetUniversity, hospital or other
- Collaborators
- Bahteem Specialized Hospital
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | Active comparator | Drug: Magnesium sulphateGroup M |
| Na CL 0.9% | Placebo comparator | Other: Na CL 0.9%group C |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and II children
Key exclusion criteria (6 listed)
- uncontrolled hypertension,
- diabetes mellitus,
- liver disease,
- kidney disease,
- heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulphateAlso: MGSO4Before 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. | Drug | Magnesium sulphate |
| Na CL 0.9%Also: isotonic saline solutionBefore induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate. | Other | Na CL 0.9% |
Primary outcome
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
6 secondary outcomes
The operative time
Time frame: Intraoperative
The anesthesia time.
Time frame: Intraoperative
ESRT responses
Time frame: After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),
Heart rate
Time frame: baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.
Mean arterial blood pressure
Time frame: Intraoperative
Anesthetic consumption
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulphate and Na CL 0.9% in people with Anesthesia, run by Wahba bakhet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of surgical field (time frame: at the end of the surgey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.