Perioperative Respiratory Adverse events_sugammadex

Respiratory Complication Clinical Trial

Official title:

Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354466
• Other study ID #: 2203-061-1305
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: Eun-hee Kim
• Phone: +82-2-2072-3664
• Email: beloveun[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

Drug:
• Sugammadex injection
sugammadex as reversal agent
• Neostigmine
neostigmine as a reversal agent

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative respiratory adverse events	the incidence of overall perioperative respiratory adverse events; oxygen desaturation < 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor	from induction of anesthesia to end of operation, about 3 hours
Secondary	bradycardia	administration of IV atropine, glycopyrrolate, epinephrine, ephedrine	from induction of anesthesia to end of operation, about 3 hours
Secondary	Cardiac arrest	documented chest compressions/defibrillation/cardioversion	from induction of anesthesia to end of operation, about 3 hours
Secondary	Anaphylaxis	administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction	from induction of anesthesia to end of operation, about 3 hours
Secondary	Allergic reaction	redness, urticaria, wheeze	from induction of anesthesia to end of operation, about 3 hours
Secondary	Bronchospasm	administration of albuterol, epinephrine	from induction of anesthesia to end of operation, about 3 hours
Secondary	Nausea and vomiting		from induction of anesthesia to end of operation, about 3 hours