CraniectomyNCT06987357
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
An observational study of Craniectomy and Sugammadex, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Craniectomy, Sugammadex, Extubation
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Jul 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group Neostigmine | Not described | |
| Group Sugammadex | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of cost in the hospital process
Measured: through study completion, an average of 3 month
Length of stay in the intensive care unit
Measured: through study completion, an average of 3 month
Early extubation rate after two different neuromuscular blocking antagonist drugs
Measured: through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 May 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniectomyStudies 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987357
- Sponsor's protocol ID
- KAEK/2021.04.116
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06987357
- Acronym / sponsor ID
- KAEK/2021.04.116
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 23 May 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Neostigmine | – | – |
| Group Sugammadex | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The amount of cost in the hospital process
Time frame: through study completion, an average of 3 month
Length of stay in the intensive care unit
Time frame: 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
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 23 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Craniectomy and Sugammadex, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 23 May 2025. 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 Turkey (Türkiye). 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?
The amount of cost in the hospital process (time frame: through study completion, an average of 3 month). The study lists 3 primary outcomes in all. 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 23 May 2025.