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

NCT02669368 | Unknown Phase 2

• 1 other identifier: 01MgRo
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Intubation condition

  Within 10 minutes after induction of anesthesia

• Surgical condition

  During surgery

Study Arms (3)

Standard dose Rocuronium

ACTIVE COMPARATOR

Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia.

Drug: Saline; Drug: Standard dose Rocuronium

Low dose Rocuronium

ACTIVE COMPARATOR

Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia.

Drug: Saline; Drug: Low dose Rocuronium

Low dose Rocuronium + Magnesium Sulfate

ACTIVE COMPARATOR

Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia.

Drug: Magnesium Sulfate; Drug: Low dose Rocuronium

Interventions

Magnesium Sulfate DRUG

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

Low dose Rocuronium + Magnesium Sulfate

Saline DRUG

Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia

Low dose Rocuronium; Standard dose Rocuronium

Standard dose Rocuronium DRUG

0.6 mg/kg of Rocuronium given with induction of anesthesia

Standard dose Rocuronium

Low dose Rocuronium DRUG

0.45 mg/kg of Rocuronium given with induction of anesthesia

Low dose Rocuronium; Low dose Rocuronium + Magnesium Sulfate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status 1 or 2.
• BMI of 25-34.9 kg/m2.
• Patients scheduled for laparoscopic cholecystectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Asyut Governorate, 71121, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride; Rocuronium

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nawal Abdelaziz Gadelrab, Professor

  Assiut University

  STUDY CHAIR

• Ola Mahmoud Wahba, Lecturer

  Assiut University Hospitals

  STUDY DIRECTOR

• Ahmed Hamada Hamed Amin, Resident

  Assiut University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 1, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

EG (1)