Effect of Magnesium on Remifentanil Induced Cough

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05237791
• Other study ID #: B-2201-731-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 3, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Magnesium sulfate
magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
• Placebo
normal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	severity of cough	mild: 1-2, moderate: 3-4, severe: = 5	from preoperative 20 minutes to induction of anesthesia
Secondary	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
Secondary	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