Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Seoul National University

Status: Completed

Conditions: Neuromuscular Block, Residual

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT03292965

B-1609-363-002

Details and patient eligibility

About

Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

Full description

At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

Exclusion criteria

• Obesity BMI over 30 kg/m2
• Impairment of renal or/and liver function
• Allergy to rocuronium, sugammadex
• (Familial) history of malignant hyperthermia
• Taking medicines which is affecting neuromuscular function

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Neostigmine

Active Comparator group

Description:

At the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

Treatment:

Drug: Neostigmine

Sugammadex

Active Comparator group

Description:

At the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

Treatment:

Drug: Sugammadex