Effect of Magnesium Sulphate Pretreatment in Pediatric Laparoscopy

Study Overview
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Brief Summary
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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 laparoscopic surgeries.

Detailed Description
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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 laparoscopic surgeries.

Official Title
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Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Laparoscopic Surgery

Conditions
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Muscle Relaxation

Intervention / Treatment
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* Drug: MgSO4
* Drug: Rocuronium Bromide
* Drug: Cis-Atracurium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium/MgSO4<br>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. Rocuronium will be administered for intubation at a dose of 0.45-0.6 mg/kg IV and Maintenance at a dose of 0.1-0.2 mg/kg IV on fixed interval | Drug: MgSO4<br>* 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.<br>* Other names: Magnesium Sulfate;Drug: Rocuronium Bromide<br>* Rocuronium will be administered for intubation at a dose of 0.45-0.6 mg/kg IV and Maintenance at a dose of 0.1-0.2 mg/kg IV on fixed interval<br>* Other names: Esmeron;|
| Active Comparator: Cis-Atracurium/MgSO4<br>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 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. | Drug: MgSO4<br>* 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.<br>* Other names: Magnesium Sulfate;Drug: Cis-Atracurium<br>* 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.<br>* Other names: Nimbex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative | 
| 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. | Intraoperative. | 
| 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. | Intraoperative. |