Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Neuromuscular Block, Residual
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT03292965
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-26
• Study Start: 2017-09-28
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	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
Neostigmine	Neostigmine	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

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative residual curarization	Immediately after entering PACU	definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of