Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2017-11-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Neuromuscular Block, Residual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal

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

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

Interventions

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Neostigmine

Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal

Intervention Type DRUG

Sugammadex

Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No