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

Muscle Relaxation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02669368
• Other study ID #: 01MgRo
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 25, 2016
• Last updated: January 29, 2016
• Start date: March 2015

Study information

• Verified date: January 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

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
• Saline
Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
• Standard dose Rocuronium
0.6 mg/kg of Rocuronium given with induction of anesthesia
• Low dose Rocuronium
0.45 mg/kg of Rocuronium given with induction of anesthesia

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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	No
Secondary	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	No
Secondary	Surgical condition	to score a surgical condition according to 7 point likert scale	During surgery	No