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Completed

NCT Number: NCT03619759

The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

This study is retrospective study. The purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16377, South Korea

About this study

Abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block during surgery. After the surgery, reversal agent of neuromuscular blocking agent is given almost every pateints who underwent general anesthesia.

Classic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. Its action mechanism is competetive antagonist of rocuronium. But cholinesterase inhibitor cannot make complete reversal in moderate or deep neuromuscular block. Its incomplete reversal which is called residual block cause respiratory complications and prolongation hospital stay.

Sugammadex has different mechanism compared to cholinesterase inhibitor. It captures neuromuscular agent, especially rocuronium, and prevent rocuronium's action. Even in deep neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect is fater and more reliable compared to cholinesterase inhibitor.

Previous studies focused on only short term outcome of sugammadex, like postanesthetic care unit (PACU) discharge time, respiratory complications in PACU.

But in this study, longer term outcome will be comapred between sugammadex group and cholinesterase inhibitor group (pyridostigmine).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects aged 21~80
  • Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017

Exclusion criteria

  • Emergency surgery
  • Paraplegia or quadriplegia
  • Bedridden state d/t various reason
  • Neuromuscular disease
  • Combined operation wth other surgery

Treatment and study plan

Sugammadex

Drug

Sugammadex injection as a reverse agent of neuromuscular blocking

Other names: Bridion

Primary outcomes

  1. Length of stay

    Time frame: admission to discharge (within 1 month)

    Length of stay in hospital

Secondary outcomes

  1. Readmission rate

    Time frame: 30 days after discharge

    Readmission or ER visit within 30 days after discharge

  2. postoperative complication rate

    Time frame: after colorectal surgery, within 30 days

    postoperative complications, heart, lung, kidney, neurovascular, infection etc Check by review discharge summary note, consultation note, and postoperative laboratory tests

  3. Time to first successful oral intake

    Time frame: within 30 days

    time interval between end of surgery and the first successful oral intake

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Acronym: Sugammadex

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Aug 20, 2019

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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