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Perioperative Respiratory Adverse events_sugammadex

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05354466
Collaborator
(none)
174
Enrollment
1
Location
2
Arms
18.1
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
Actual Study Start Date :
Jun 27, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sugammadex as reversal agent

Drug: Sugammadex injection
sugammadex as reversal agent
Active Comparator: Neostigmine as reversal agent

Drug: Neostigmine
neostigmine as a reversal agent

Outcome Measures

Primary Outcome Measures

  1. Perioperative respiratory adverse events [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

Secondary Outcome Measures

  1. bradycardia [from induction of anesthesia to end of operation, about 3 hours]

    administration of IV atropine, glycopyrrolate, epinephrine, ephedrine

  2. Cardiac arrest [from induction of anesthesia to end of operation, about 3 hours]

    documented chest compressions/defibrillation/cardioversion

  3. Anaphylaxis [from induction of anesthesia to end of operation, about 3 hours]

    administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction

  4. Allergic reaction [from induction of anesthesia to end of operation, about 3 hours]

    redness, urticaria, wheeze

  5. Bronchospasm [from induction of anesthesia to end of operation, about 3 hours]

    administration of albuterol, epinephrine

  6. Nausea and vomiting [from induction of anesthesia to end of operation, about 3 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
Exclusion Criteria:

  • a recent history of upper respiratory tract infection within 2 weeks of surgery

  • allergic reaction to sugammadex

  • renal failure

  • liver failure

  • arrhythmia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul national university hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eun-hee Kim, Clinical associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05354466
Other Study ID Numbers:
  • 2203-061-1305
First Posted:
Apr 29, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neostigmine

Study Results

No Results Posted as of Jul 12, 2022