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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510337
Recruitment Status : Completed
First Posted : August 12, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Study Description
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Brief Summary:
This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium

Condition or disease Intervention/treatment Phase
Anesthesia Drug: standard rocuronium dose Drug: Magnesium sulfate Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects the Depth of Blockade in Cancer Patients Undergoing Direct Laryngoscope Surgical Procedures
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : February 20, 2021
Actual Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: low dose rocuronium


Outcome Measures
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Primary Outcome Measures :
  1. Onset and duration of muscle relaxant [ Time Frame: 90 minutes ]
    Onset time of muscle relaxant and duration


Secondary Outcome Measures :
  1. Degree of muscle relaxation [ Time Frame: 90 minutes ]
    depth of blockade


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510337


Locations
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Egypt
National Cancer Institute
Cairo, Egypt, 11796
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Principal Investigator: Walaa Y Elsabeeny, MD Lecturer
Study Director: Mohamed A Wadod, MD Lecturer
More Information
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Responsible Party: Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04510337    
Other Study ID Numbers: 201617031.2P
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Magnesium Sulfate
Rocuronium
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents