Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

Phase 2

Completed

• Conditions: Anesthesia, General; Neuromuscular Blockade
• Interventions: Drug: Sugammadex Injection 4mg/kg; Drug: Neuromuscular reversal agent injection; Drug: Sugammadex Injection 2mg/kg; Drug: Sugammadex Injection 8mg/kg

• Registration Number: NCT03943888
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.

Detailed Description

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for early reversal of neuromuscular blockade, aged between 2 and 18 years old.

After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. 15 minutes after rocuronium administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.

For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-08-12
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2022-10
• Results First Submitted: 2022-10-20
• Results First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Results First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All of below

• Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
• Aged between 2 and 17
• American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria

Any of below

• One or more legal guardian declines to enroll in the study
• History of hypersensitivity to any anesthetic agents including rocuronium
• Presence of underlying cardiovascular or genitourinary disease
• Under usage of neuromuscular blocking agents before surgery
• Under usage of drugs influencing the effect of neuromuscular blocking agents
• History of malignant hyperthermia
• Anticipation of massive hemorrhage during surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex 4mg	Sugammadex Injection 4mg/kg	Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Conventional reversal	Neuromuscular reversal agent injection	Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Sugammadex 2mg	Sugammadex Injection 2mg/kg	Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex 8mg	Sugammadex Injection 8mg/kg	Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration

Primary Outcome Measures

Name	Time	Method
Neuromuscular Recovery	up to 30 minutes to 1 hour	Time to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentrations	From anesthetic induction to 480 minutes after sugammadex administration	Plasma concentrations of rocuronium and sugammadex sodium

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of