Perioperative Respiratory Adverse events_sugammadex

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

Study Overview

• Status: Completed
• Conditions: Respiratory Complication
• Intervention / Treatment: Drug: Sugammadex injection; Drug: Neostigmine

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
bradycardia	administration of IV atropine, glycopyrrolate, epinephrine, ephedrine	from induction of anesthesia to end of operation, about 3 hours
Cardiac arrest	documented chest compressions/defibrillation/cardioversion	from induction of anesthesia to end of operation, about 3 hours
Anaphylaxis	administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction	from induction of anesthesia to end of operation, about 3 hours
Allergic reaction	redness, urticaria, wheeze	from induction of anesthesia to end of operation, about 3 hours
Bronchospasm	administration of albuterol, epinephrine	from induction of anesthesia to end of operation, about 3 hours
Nausea and vomiting		from induction of anesthesia to end of operation, about 3 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): September 4, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: 2203-061-1305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes