Effect of Magnesium on Remifentanil Induced Cough

Phase 4

• Conditions: Cough
• Interventions: Drug: Placebo; Drug: Magnesium sulfate

• Registration Number: NCT05237791
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-29
• Status Verified: 2022-02
• Study Start: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Placebo	normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion)
magnesium group	Magnesium sulfate	magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
severity of cough	from preoperative 20 minutes to induction of anesthesia	mild: 1-2, moderate: 3-4, severe: ≥ 5
laryngeal mask airway (LMA) insertion compliance	from preoperative 20 minutes to induction of anesthesia	Assess the number of trials prior to successful laryngeal mask insertion and the need for administration of a neuromuscular blocker.
lung compliance	from induction of anesthesia to finish of surgery	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.