Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Anesthesia, General; Neuromuscular Blockade

Treatments: Drug: Sugammadex Injection 8mg/kg; Drug: Sugammadex Injection 2mg/kg; Drug: Sugammadex Injection 4mg/kg; Drug: Neuromuscular reversal agent injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03943888

1904-149-1029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Sugammadex 2mg

Experimental group

Description:

Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration

Treatment:

Drug: Sugammadex Injection 2mg/kg

Sugammadex 4mg

Experimental group

Description:

Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration

Treatment:

Drug: Sugammadex Injection 4mg/kg

Sugammadex 8mg

Experimental group

Description:

Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration

Treatment:

Drug: Sugammadex Injection 8mg/kg

Conventional reversal

Active Comparator group

Description:

Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration

Treatment:

Drug: Neuromuscular reversal agent injection