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

Phase 2

• Conditions: Muscle Relaxation
• Interventions: Drug: Saline; Drug: Magnesium Sulfate; Drug: Low dose Rocuronium; Drug: Standard dose Rocuronium

• Registration Number: NCT02669368
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-29
• Last Update Submitted: 2016-01-29
• Study First Posted: 2016-02-01
• Last Update Posted: 2016-02-01
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose Rocuronium	Saline	Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia.
Low dose Rocuronium	Saline	Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia.
Low dose Rocuronium	Low dose Rocuronium	Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia.
Low dose Rocuronium + Magnesium Sulfate	Magnesium Sulfate	Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia.
Low dose Rocuronium + Magnesium Sulfate	Low dose Rocuronium	Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia.
Standard dose Rocuronium	Standard dose Rocuronium	Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt