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Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery

ConditionMuscle Relaxation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age2-12
SponsorAssiut University

About this trial

In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age group 2-12 years old

Both genders

Children who will be scheduled to undergo elective laparoscopic surgeries.

Patients with American Society of Anesthesiologist physical status classification of 1 or 2-

Disqualifiers

Patients who are beyond the selected age group.

Patients on medications that interfered with muscle activity.

Allergy to medications used in this study.

Neuro-muscular diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MgSO4

    Drug

    The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.

  • Cis-Atracurium

    Drug

    Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Cis/atracurium/saline placeboPlacebo comparator 1 intervention
Group B: Cis-Atracurium/MgSO4Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

The time of no response to nerve stimulation (seconds)

Neuromuscular monitoring will be performed using acceleromyography with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). Period of no response will be defined as the time period with no response to TOF stimulation (intense and deep NMB).

Time frame
Intraoperative

Secondary outcomes

1

Duration of deep NMB (seconds)

The time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation.

Time frame
Intraoperative
2

The duration of moderate NMB (seconds)

the time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation one to three out of four twitches.

Time frame
Intraoperative.
3

NMB onset time (in seconds).

The time elapsed, in minutes, from the start of the administration of muscle relaxant; cis-atracurium or rocuronium injection to 95% of T1 depression.

Time frame
Intraoperative.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
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