Using magnesium sulphate to improve muscle relaxation in children during abdominal surgery

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

This study is testing if giving magnesium sulphate before surgery can help children aged 2 to 12 relax their muscles better during abdominal surgery compared to standard medications.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 2 Years to 12 Years
• Sex: All
• Sponsor: Assiut University (Academic / other)
• Locations: 2 sites (Asyut, Assiut Governorate and 1 other locations)
• Trial ID: NCT05736744 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of magnesium sulphate pretreatment on the onset and duration of deep neuromuscular blockade in children undergoing elective open abdominal surgeries. The researchers will compare the efficacy of magnesium sulphate with two neuromuscular blocking agents, rocuronium and Cis-Atracurium. The goal is to enhance surgical conditions and reduce postoperative complications by improving muscle relaxation. The study will involve children aged 2 to 12 years and will monitor the effects of magnesium on neuromuscular function during surgery.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 12 years scheduled for elective laparoscopic surgeries with a physical status classification of 1 or 2.

Not a fit: Patients with neuromuscular diseases, renal or hepatic impairment, or those allergic to the medications used in the study may not benefit.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced postoperative pain for pediatric patients.

How similar studies have performed: Limited data exists on the effects of magnesium sulphate in this context, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age group 2-12 years old
2. Both genders
3. Children who will be scheduled to undergo elective laparoscopic surgeries.
4. Patients with American Society of Anesthesiologist physical status classification of 1 or 2-

Exclusion Criteria:

1. Patients who are beyond the selected age group.
2. Patients on medications that interfered with muscle activity.
3. Allergy to medications used in this study.
4. Neuro-muscular diseases.
5. Renal or hepatic impairment.
6. Hypermagnesemia (\>2.5 mmol) or hypomagnesemia (\<1.7 mmol).
7. Parental refusal to participate in the study

Where this trial is running

Asyut, Assiut Governorate and 1 other locations

• Pediatric hospital, faculty of medicine, Assiut university — Asyut, Assiut Governorate, Egypt (Recruiting)
• Pediatric hospital — Asyut, Assiut Governorate, Egypt (Recruiting)

Study contacts

• Principal investigator: Hala Abdel-Ghaffar, MD — Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
• Study coordinator: Hala S Abdel-Ghaffar, MD

Conditions Muscle Relaxation