Respiratory ComplicationPhase 4NCT05354466
Perioperative Respiratory Adverse events_sugammadex
A Phase 4 study testing Sugammadex injection and Neostigmine in people with Respiratory Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Respiratory Complication
- What is being tested?
- Sugammadex injection and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2022to 4 Sep 2024
- Phase
- Phase 4
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
Who cannot join
- a recent history of upper respiratory tract infection within 2 weeks of surgery
- allergic reaction to sugammadex
- renal failure
- liver failure
- arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy
- Conditions
- Respiratory Complication
- Being tested
- Sugammadex injection, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex injectionDrug
sugammadex as reversal agent
NeostigmineDrug
neostigmine as a reversal agent
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex as reversal agent | Experimental | Not described Receives: Drug: Sugammadex injection |
| Neostigmine as reversal agent | Active comparator | Not described Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative respiratory adverse events
the incidence of overall perioperative respiratory adverse events; oxygen desaturation < 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor
Measured: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes (6)
bradycardia
administration of IV atropine, glycopyrrolate, epinephrine, ephedrine
Measured: from induction of anesthesia to end of operation, about 3 hours
Cardiac arrest
documented chest compressions/defibrillation/cardioversion
Measured: from induction of anesthesia to end of operation, about 3 hours
Anaphylaxis
administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction
Measured: from induction of anesthesia to end of operation, about 3 hours
Allergic reaction
redness, urticaria, wheeze
Measured: from induction of anesthesia to end of operation, about 3 hours
Bronchospasm
administration of albuterol, epinephrine
Measured: from induction of anesthesia to end of operation, about 3 hours
Nausea and vomiting
Measured: from induction of anesthesia to end of operation, about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start27 Jun 2022
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354466
- Sponsor's protocol ID
- 2203-061-1305
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05354466
- Acronym / sponsor ID
- 2203-061-1305
- Conditions
- Respiratory Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 29 Apr 2022 (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.
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex as reversal agent | Experimental | Drug: Sugammadex injection |
| Neostigmine as reversal agent | Active comparator | Drug: Neostigmine |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
Key exclusion criteria (5 listed)
- a recent history of upper respiratory tract infection within 2 weeks of surgery
- allergic reaction to sugammadex
- renal failure
- liver failure
- arrhythmia
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 |
|---|---|---|
| Sugammadex injectionsugammadex as reversal agent | Drug | Sugammadex as reversal agent |
| Neostigmineneostigmine as a reversal agent | Drug | Neostigmine as reversal agent |
Primary outcome
Perioperative respiratory adverse events
Time frame: from induction of anesthesia to end of operation, about 3 hours
the incidence of overall perioperative respiratory adverse events; oxygen desaturation < 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor
6 secondary outcomes
bradycardia
Time frame: from induction of anesthesia to end of operation, about 3 hours
Cardiac arrest
Time frame: from induction of anesthesia to end of operation, about 3 hours
Anaphylaxis
Time frame: from induction of anesthesia to end of operation, about 3 hours
Allergic reaction
Time frame: from induction of anesthesia to end of operation, about 3 hours
Bronchospasm
Time frame: from induction of anesthesia to end of operation, about 3 hours
Nausea and vomiting
Time frame: from induction of anesthesia to end of operation, about 3 hours
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 20 Sep 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.
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?
A Phase 4 study testing Sugammadex injection and Neostigmine in people with Respiratory Complication, run by Seoul National University 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 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: finished, as of the sponsor's last update on 20 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Perioperative respiratory adverse events (time frame: from induction of anesthesia to end of operation, about 3 hours). 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 20 Sep 2024.