Magnesium Sulfate Effects on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy.

Official Title
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Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy

Conditions
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Muscle Relaxation

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Saline
* Drug: Standard dose Rocuronium
* Drug: Low dose Rocuronium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status 1 or 2. BMI of 25-34.9 kg/m2. Patients scheduled for laparoscopic cholecystectomy. Exclusion Criteria: Severe respiratory or cardiac disease. Hepatic or renal function impairment. Neuromuscular disease. Patients on medications affecting neuromuscular function. Patients with known allergy to the drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose Rocuronium<br>Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia. | Drug: Saline<br>* Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia<br>Drug: Standard dose Rocuronium<br>* 0.6 mg/kg of Rocuronium given with induction of anesthesia<br>|
| Active Comparator: Low dose Rocuronium<br>Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia. | Drug: Saline<br>* Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia<br>Drug: Low dose Rocuronium<br>* 0.45 mg/kg of Rocuronium given with induction of anesthesia<br>|
| Active Comparator: Low dose Rocuronium + Magnesium Sulfate<br>Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia. | Drug: Magnesium Sulfate<br>* Patients in each group receive Magnesium sulfate 30 mg/kg in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia<br>Drug: Low dose Rocuronium<br>* 0.45 mg/kg of Rocuronium given with induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of onset the action of Rocuronium | by using the TOF watch nerve stimulator | Time from injection of Rocuronium till T1 suppression more than 95% up to 10 minutes. | 
| The time at which Maximal suppression | by using the TOF watch nerve stimulator | Time from the injection of Rocuronium to T1 maximal suppression time (TOF=0) up to an hour. | 
| Reversal of Rocuronium | by using the TOF watch nerve stimulator | Time from injection of Rocuronium till reversal of T1 (TOF=25%) around an hour after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation condition | to score intubation condition on the basis of 6 items: Jaw relaxation, laryngoscopy, vocal cord position, moving of limbs, coughing & change in heart rate. | Within 10 minutes after induction of anesthesia | 
| Surgical condition | to score a surgical condition according to 7 point likert scale | During surgery |