Minimally Invasive Cardiac SurgeryNCT04957836
Postoperative Respiratory Complications According to Neuromuscular Block Reversal After MICS
An observational study of Minimally Invasive Cardiac Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Cardiac Surgery
- What is being tested?
- reversal with sugammadex
- How many people
- 1,216 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2021to 29 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Minimally Invasive Cardiac Surgery
- Being tested
- reversal with sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reversal with sugammadexOther
reversal with sugammadex for immediate extubation in the operating room
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative respiratory complications
Postoperative respiratory complications
Measured: 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
the length of intensive care unit stay
Measured: during ICU hospitalization (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 May 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957836
- Sponsor's protocol ID
- 05-2021-091
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04957836
- Acronym / sponsor ID
- 05-2021-091
- Conditions
- Minimally Invasive Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reversal with sugammadexreversal with sugammadex for immediate extubation in the operating room | Other | – |
Primary outcome
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
1 secondary outcome
the length of intensive care unit stay
Time frame: during ICU hospitalization (up to 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Kim, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Cardiac Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.