Postoperative Respiratory Complications According to Neuromuscular Block Reversal After MICS

Postoperative Respiratory Complications According to Neuromuscular Block Reversal With Sugammadex for Immediate Extubation in the Operating Room After Minimally Invasive Cardiac Surgery (MICS): a Retrospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Minimally Invasive Cardiac Surgery
• Intervention / Treatment: Other: reversal with sugammadex

Detailed Description

The enhanced recovery after surgery program (ERAS program) has been introduced across several surgical fields, and its benefits are well known, mainly in perioperative colorectal surgery, pancreatic surgery, urology and gynecology surgery. On the other hand, although there are suggestions for an early recovery program after surgery in the field of cardiac surgery, it is still in its infancy. Minimally invasive cardiac surgery has advantages over open thoracic surgery, such as faster recovery, less bleeding and transfusion, and a reduction in the frequency of arrhythmias, making it suitable for applying an early recovery program after surgery. For an early recovery program after surgery, a multidisciplinary approach is required throughout the surgery period, and among them, early endotracheal extubation, which has been emphasized before, is known to reduce hospital stay and mortality. In addition, such early endotracheal extubation includes extubation of the endotracheal tube in the operating room immediately after completion of surgery as well as within 6 hours of entering the intensive care unit after the end of surgery. For the reversibility of neuromuscular block, neostigmine, pyridostigmine, an acetylcholinesterase inhibitor, or sugammadex, a selective neuromuscular blocker binding agent, are mainly used. It is known to reduce the incidence of pulmonary complications. However, there is no study on the frequency of postoperative respiratory complications following neuromuscular block and reversibility using the Rocuronium-Sugarmadex combination in minimally invasive cardiac surgery.

• Study Type: Observational
• Enrollment (Actual): 1216

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the length of intensive care unit stay	the length of intensive care unit stay	during ICU hospitalization (up to 6 months)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Hee Young Kim, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 05-2021-091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No