Effect of Magnesium on Remifentanil Induced Cough

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05237791
Collaborator
(none)
78
2
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Magnesium sulfate
  • Drug: Placebo
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity
Anticipated Study Start Date :
Feb 3, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. severity of cough [from preoperative 20 minutes to induction of anesthesia]

    mild: 1-2, moderate: 3-4, severe: ≥ 5

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JiWon Han, assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT05237791
Other Study ID Numbers:
  • B-2201-731-001
First Posted:
Feb 14, 2022
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022