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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02669368

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Relaxation	Drug: Magnesium Sulfate Drug: Saline Drug: Standard dose Rocuronium Drug: Low dose Rocuronium	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Arms and Interventions

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: 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 Drug: Low dose Rocuronium 0.45 mg/kg of Rocuronium given with induction of anesthesia

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: 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

Drug: Low dose Rocuronium

0.45 mg/kg of Rocuronium given with induction of anesthesia

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospitals	Assiut		Egypt	71121

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Hamada Hamed, Dr., Assiut University

ClinicalTrials.gov Identifier:

NCT02669368

Other Study ID Numbers:

01MgRo

First Posted:

Feb 1, 2016

Last Update Posted:

Feb 1, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Magnesium Sulfate

Rocuronium

Study Results

No Results Posted as of Feb 1, 2016