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Completed

NCT Number: NCT03292965

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

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

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Key information

Conditions

Neuromuscular Block, Residual Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine

Drug

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

Sugammadex

Drug

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

Other names: Bridion

Primary outcomes

  1. the incidence of postoperative residual curarization

    Time frame: Immediately after entering PACU

    definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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