SugammadexNCT05751603
Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex
A study testing sugammadex in people with Sugammadex and Extubation, run by Ajou University School of Medicine.
Trial summary
After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Sugammadex, Extubation, Smooth Emergence
- What is being tested?
- sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2024to 3 Oct 2025
- Phase
- Interventional
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing general anesthesia for thyroid surgery.
- aged between 19 and 64 years
- American Society of Anesthesiologists physical status I and II
Who cannot join
- patients with malformation or tumor of the upper respiratory tract
- patients with risk of aspiration
- obese cases with a BMI > 35
- patients in which tracheal intubation was difficult
- refusal to participate in research
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation
After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .
Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.
Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).
- Conditions
- Sugammadex, Extubation, Smooth Emergence
- Being tested
- sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
sugammadex is administered just after extubation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation) |
| Experimental group | Experimental | sugammadex is administered just after extubation. Receives: Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation quality score
score based on the incidence and severity of coughing straining
Measured: immediate after extubation
Secondary outcomes (3)
time to respiration
time from withdrawal of anesthetics to respiration
Measured: immediate after extubation
time to extubation
time from withdrawal of anesthetics to extubation
Measured: immediate after extubation
sore throat in postanesthetic care unit
Scores obtained by questioning the patient in postanesthetic care unit
Measured: in postanesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start3 Oct 2024 (estimated)
- Primary completion3 Oct 2025 (estimated)
- Study completion3 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SugammadexStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751603
- Sponsor's protocol ID
- AJOUIRB-INT-2022-173
- Status last verified
- Jul 2024
- First submitted
- 21 Feb 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation
- ClinicalTrials.gov ID
- NCT05751603
- Acronym / sponsor ID
- AJOUIRB-INT-2022-173
- Conditions
- Sugammadex, Extubation, Smooth Emergence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 3 Oct 2024 (estimated)
- Primary completion
- 3 Oct 2025 (estimated)
- Study completion
- 3 Oct 2025 (estimated)
- First posted
- 2 Mar 2023 (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.
After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .
Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.
Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation) |
| Experimental group | Experimental | Drug: sugammadexsugammadex is administered just after extubation. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients undergoing general anesthesia for thyroid surgery.
- aged between 19 and 64 years
- American Society of Anesthesiologists physical status I and II
Key exclusion criteria (5 listed)
- patients with malformation or tumor of the upper respiratory tract
- patients with risk of aspiration
- obese cases with a BMI > 35
- patients in which tracheal intubation was difficult
- refusal to participate in research
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 |
|---|---|---|
| sugammadexsugammadex is administered just after extubation | Drug | Experimental group |
Primary outcome
extubation quality score
Time frame: immediate after extubation
score based on the incidence and severity of coughing straining
3 secondary outcomes
time to respiration
Time frame: immediate after extubation
time to extubation
Time frame: immediate after extubation
sore throat in postanesthetic care unit
Time frame: in postanesthetic care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing sugammadex in people with Sugammadex and Extubation, run by Ajou University School of Medicine.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yun jeong chae, Ph D (+82312195689, yjchae06@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation quality score (time frame: immediate after extubation). 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 25 Jul 2024.