- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06987357
- Original Trial
Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery
May 15, 2025 updated by: Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
The aim of this study was to retrospectively investigate the effects of sugammadex or neostigmine, which are routinely used after the completion of surgery to antagonize (reverse) neuromuscular blockade in adult patients undergoing cranial surgery under general anesthesia, on early extubation in the operating room, intensive care unit admission and length of stay, length of hospital stay, and hospital costs.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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İstanbul, Turkey
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Among the patients who underwent cranial surgery under sevoflurane anesthesia and whose neuromuscular blockade was provided with rocuronium, the patients whose neuromuscular blockade was antagonized with neostigmine or sugammadex and who were admitted to the intensive care unit postoperatively were evaluated.
Description
Inclusion Criteria:
- Patients from the American Society of Anesthesiology (ASA) I-II-III group,
- over the age of 18,
- who underwent elective surgery,
- underwent general anesthesia with sevoflurane anesthesia from volatile anesthetics,
- used rocuronium as a neuromuscular blocking agent
Exclusion Criteria:
- Patients aged 18 and under,
- ASA IV and above,
- who underwent surgery under emergency conditions,
- who have incomplete follow-up form records and electronic media data,
- who were taken to the intensive care unit without neuromuscular blockade antagonism due to long surgery,
- who were treated with a neuromuscular blocking agent other than rocuronium,
- who were treated with a volatile anesthetic other than sevoflurane or with total intravenous anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group Neostigmine
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Group Sugammadex
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The amount of cost in the hospital process
Time Frame: through study completion, an average of 3 month
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through study completion, an average of 3 month
|
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Length of stay in the intensive care unit
Time Frame: through study completion, an average of 3 month
|
through study completion, an average of 3 month
|
|
Early extubation rate after two different neuromuscular blocking antagonist drugs
Time Frame: through study completion, an average of 3 month
|
through study completion, an average of 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
May 9, 2025
First Submitted That Met QC Criteria
May 15, 2025
First Posted (Actual)
May 23, 2025
Study Record Updates
Last Update Posted (Actual)
May 23, 2025
Last Update Submitted That Met QC Criteria
May 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- KAEK/2021.04.116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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