Postoperative Respiratory Complications According to Neuromuscular Block Reversal With Sugammadex After Minimally Invasive Cardiac Surgery

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04957836
Collaborator
(none)
1,216
1
1.3
949

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1216 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Postoperative Respiratory Complications According to Neuromuscular Block Reversal With Sugammadex for Immediate Extubation in the Operating Room After Minimally Invasive Cardiac Surgery: a Retrospective Observational Study
Actual Study Start Date :
May 21, 2021
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 29, 2021

Outcome Measures

Primary Outcome Measures

  1. 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)]

    Postoperative respiratory complications

Secondary Outcome Measures

  1. the length of intensive care unit stay [during ICU hospitalization (up to 6 months)]

    the length of intensive care unit stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Yangsan Hospital Yangsan Korea, Republic of

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kim Hee Young, Clinical associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT04957836
Other Study ID Numbers:
  • 05-2021-091
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 12, 2021