Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade

March 4, 2021 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects the Depth of Blockade in Cancer Patients Undergoing Direct Laryngoscope Surgical Procedures

This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparing the effect of magnesium sulphate combined to low dose rocuronium versus standard dose rocuronium in cancer patients undergoing direct laryngoscopy for laryngeal tumors regarding intubating conditions, intraoperative relaxation, depth of anesthesia and recovery time.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with Laryngeal tumors

ASA I-II

Age 30-70 years

Exclusion Criteria:

Renal and or hepatic insufficiency

Neuromuscular disease

Large glottic and/or supra-glottic lesions with or without breathing difficulties

Known allergy to any of the used drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard rocuronium
patients received rocuronium 0.6mg/kg
Drug: standard rocuronium dose
0.6 mg/kg rocuronium during induction of anesthesia
Other Names:
  • standard dose rocuronium
Experimental: Magnesium
patients received 100 ml saline with 50mg/kg magnesium sulphate infusion over 10 minutes
Drug: Magnesium sulfate
50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium
Other Names:
  • low dose rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset and duration of muscle relaxant
Time Frame: 90 minutes
Onset time of muscle relaxant and duration
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of muscle relaxation
Time Frame: 90 minutes
depth of blockade
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Director: Mohamed A Wadod, MD, Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

February 20, 2021

Study Completion (Actual)

February 20, 2021

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201617031.2P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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