Effect of Magnesium on Remifentanil Induced Cough

NCT05237791 | Unknown Phase 4

• 1 other identifier: B-2201-731-001
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• severity of cough

  from preoperative 20 minutes to induction of anesthesia

• laryngeal mask airway (LMA) insertion compliance

  from preoperative 20 minutes to induction of anesthesia

• lung compliance

  from induction of anesthesia to finish of surgery

Study Arms (2)

magnesium group

EXPERIMENTAL

magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

Drug: Magnesium sulfate

control group

PLACEBO COMPARATOR

normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion)

Drug: Placebo

Interventions

Magnesium sulfate DRUG

magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

magnesium group

Placebo DRUG

normal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

MeSH Terms

Conditions

Cough

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 14, 2022
• Study Start: February 3, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02