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

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

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.

Study Overview

• Status: Unknown
• Conditions: Muscle Relaxation
• Intervention / Treatment: Drug: Saline; Drug: Standard dose Rocuronium; Drug: Low dose Rocuronium; Drug: Magnesium Sulfate

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71121
    • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Nawal Abdelaziz Gadelrab, Professor, Assiut University; Study Director: Ola Mahmoud Wahba, Lecturer, Assiut university hospitals; Principal Investigator: Ahmed Hamada Hamed Amin, Resident, Assiut university hospitals

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Neuromuscular Agents; Tocolytic Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Magnesium Sulfate; Rocuronium
• Other Study ID Numbers: 01MgRo