Clinical trial NCT03619759: The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
Official title: The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome, Fatal
Keywords: Sugammadex
Colorectal surgery
postoperative complication
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 585
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer from Jan, 2012 to Dec, 2017

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: admission to discharge (within 1 month)
Secondary outcomes:
measure: Readmission rate
timeFrame: 30 days after discharge
measure: postoperative complication rate
timeFrame: after colorectal surgery, within 30 days
measure: Time to first successful oral intake
timeFrame: within 30 days
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References: