The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

Completed

• Conditions: Outcome, Fatal
• Interventions: Drug: Sugammadex

• Registration Number: NCT03619759
• Lead Sponsor: Ajou University School of Medicine

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).

Study Timeline

• Study Start: 2018-03-22
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation

Primary Outcome Measures

Name	Time	Method
Length of stay	admission to discharge (within 1 month)	Length of stay in hospital

Secondary Outcome Measures

Name	Time	Method
Readmission rate	30 days after discharge	Readmission or ER visit within 30 days after discharge
Time to first successful oral intake	within 30 days	time interval between end of surgery and the first successful oral intake
postoperative complication rate	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

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of