Effect of Magnesium on Remifentanil Induced Cough

Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity

The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration.

The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.

Study Overview

• Status: Not yet recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: Magnesium sulfate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2

Exclusion Criteria:

• When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
• If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
• If you are taking opioid analgesics or magnesium for other reasons
• Patients with hypermagnesemia
• Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
• Pregnant or lactating women
• Patients with myasthenia gravis
• Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin)
• In case of hypersensitivity to magnesium
• Patients with a history of hypersensitivity to propofol and any of its components
• Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: magnesium group; magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)	Drug: Magnesium sulfate; magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
Placebo Comparator: control group; normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion)	Drug: Placebo; normal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
remifentanil induced cough	To evaluate whether coughing occurs during anesthesia induction from the start of remifentanil infusion to the completion of laryngeal mask insertion.	from preoperative 20 minutes to induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of cough	mild: 1-2, moderate: 3-4, severe: ≥ 5	from preoperative 20 minutes to induction of anesthesia
laryngeal mask airway (LMA) insertion compliance	Assess the number of trials prior to successful laryngeal mask insertion and the need for administration of a neuromuscular blocker.	from preoperative 20 minutes to induction of anesthesia
lung compliance	Poor compliance of mechanical ventilation is defined as a difference between the set tidal volume and the actual tidal volume value applied to the patient by 100ml or more.	from induction of anesthesia to finish of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 3, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: B-2201-731-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No