Clinical trial NCT05736744: Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Muscle Relaxation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To 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 laparoscopic surgeries.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: The time of no response to nerve stimulation (seconds)
timeFrame: Intraoperative
Secondary outcomes:
measure: Duration of deep NMB (seconds)
timeFrame: Intraoperative
measure: The duration of moderate NMB (seconds)
timeFrame: Intraoperative.
measure: NMB onset time (in seconds).
timeFrame: Intraoperative.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Pediatric hospital, faculty of medicine, Assiut university
state: Assiut governorate
city: Assiut
country: Egypt
facility: Pediatric hospital
state: Assiut governorate
Study officials:
affiliation: Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
name: Hala Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: