Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MgSO4, Cis-Atracurium.
- Who it may be relevant to
- Registry conditions: Muscle Relaxation. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications, including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation. 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.
Interventions
- Drug MgSO4
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. - Drug Cis-Atracurium
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.
Primary outcome measures
- The time of no response to nerve stimulation (seconds) [Time frame: Intraoperative]
Secondary outcome measures (3)
- Duration of deep NMB (seconds) [Time frame: Intraoperative]
- The duration of moderate NMB (seconds) [Time frame: Intraoperative.]
- NMB onset time (in seconds). [Time frame: Intraoperative.]
Eligibility criteria
Inclusion criteria
- 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-
Exclusion criteria
- 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.
- Renal or hepatic impairment.
- Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
- Parental refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Pediatric hospital, faculty of medicine, Assiut university — Asyut
- Pediatric hospital — Asyut
Identifiers
NCT: NCT05736744 · 04-2022-200028