Actively Recruiting
Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Abdominal Surgery
Led by Assiut University · Updated on 2025-01-20
58
Participants Needed
2
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular block caused by rocuronium compared with cisatracurium in children undergoing elective open abdominal surgeries. Deep neuromuscular blockade is increasingly used to improve surgical conditions and reduce postoperative complications, but limited data exist on how magnesium sulphate affects the duration and response to nerve stimulation during such blocks. Children in this study will be randomly assigned to receive either saline or magnesium sulphate infusion 20 minutes before anesthesia induction. Both groups will then receive cisatracurium for intubation and maintenance at specified doses. The study evaluates how magnesium sulphate pretreatment influences the timing and depth of neuromuscular blockade compared to placebo. Participants will undergo monitoring during surgery to measure the time of no response to nerve stimulation, duration of deep and moderate neuromuscular blockade, and onset time of the blockade. These assessments will occur intraoperatively with neuromuscular monitoring to track muscle relaxation levels. The study is designed as a randomized, triple-blind trial and will include children aged 2 to 12 years undergoing laparoscopic abdominal surgery.
CONDITIONS
Brief Title
Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age group 2-12 years old
- Both genders
- Children scheduled for elective laparoscopic surgeries
- American Society of Anesthesiologist physical status classification of 1 or 2
You will not qualify if you...
- Patients outside the age group 2-12 years
- Taking medications that interfere with muscle activity
- Allergy to study medications
- Neuromuscular diseases
- Renal or hepatic impairment
- Hypermagnesemia or hypomagnesemia
- Parental refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of surgery and anesthesia
Participants receive magnesium sulphate or placebo infusion before anesthesia induction, followed by administration of Cis-Atracurium during surgery to achieve neuromuscular blockade.
1 treatment period during surgery
Trial Site Locations
Total: 2 locations
1
Pediatric hospital, faculty of medicine, Assiut university
Asyut, Assiut Governorate, Egypt, 715715
Actively Recruiting
2
Pediatric hospital
Asyut, Assiut Governorate, Egypt, 715715
Actively Recruiting
Research Team
H
Hala S Abdel-Ghaffar, MD
H
Heba S Hassan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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