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Completed

NCT Number: NCT04957836

Postoperative Respiratory Complications According to Neuromuscular Block Reversal After MICS

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.

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Key information

Conditions

Minimally Invasive Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reversal with sugammadex

Other

reversal with sugammadex for immediate extubation in the operating room

Primary outcomes

  1. Postoperative respiratory complications

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

    Postoperative respiratory complications

Secondary outcomes

  1. the length of intensive care unit stay

    Time frame: during ICU hospitalization (up to 6 months)

    the length of intensive care unit stay

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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