Postoperative Respiratory Complications According to Neuromuscular Block Reversal After MICS

NCT04957836 | Completed

• 1 other identifier: 05-2021-091
• Study Type: observational
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative respiratory complications according to the type of drug (sugammadex, pyridostigmine) used for reversible neuromuscular block when extubating an endotracheal tube in the operating room after minimally invasive cardiac surgery, and the length of intensive care unit stay are going to be checked. Through these results, it will be investigated whether the use of rocuronium-sugarmadex for neuromuscular block and reversal in patients undergoing minimally invasive cardiac surgery is clinically useful.

Conditions

Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative respiratory complications

  Postoperative respiratory complications

  from time point of extubation in the operating room to time point of transferring patient to general ward (up to 6 months)

Secondary Outcomes (1)

• the length of intensive care unit stay

  during ICU hospitalization (up to 6 months)

Interventions

reversal with sugammadex OTHER

reversal with sugammadex for immediate extubation in the operating room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the case of an endotracheal tube extubation in the operating room among adult patients over the age of 18 who underwent minimally invasive cardiac surgery

You may qualify if:

• In the case of an endotracheal tube extubation in the operating room among adult patients over the age of 18 who underwent minimally invasive cardiac surgery

You may not qualify if:

• Emergency surgery
• If the patient has severe uncontrolled lung disease
• In case of neuromuscular block using cisatracurium and rocuronium together
• When neuromuscular block and reversal using cysatracurium-pyridostigmine or rocuronium-sugammadex combinations are not performed

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Hee Young Kim, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: May 21, 2021
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

KR (1)