The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery (Sugammadex)

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.

Study Overview

• Status: Completed
• Conditions: Outcome, Fatal
• Intervention / Treatment: Drug: Sugammadex

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 Type: Observational
• Enrollment (Actual): 585

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16377
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sugammadex; Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation	Drug: Sugammadex; Sugammadex injection as a reverse agent of neuromuscular blocking; Other Names: Bridion
Non-sugammadex; Patients who didn't use sugammadex Pyridostigmine 15~20mg intravenous, at the end of surgery, before extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay in hospital	admission to discharge (within 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate	Readmission or ER visit within 30 days after discharge	30 days after discharge
postoperative complication rate	postoperative complications, heart, lung, kidney, neurovascular, infection etc Check by review discharge summary note, consultation note, and postoperative laboratory tests	after colorectal surgery, within 30 days
Time to first successful oral intake	time interval between end of surgery and the first successful oral intake	within 30 days

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: postoperative complication; Colorectal surgery; Sugammadex
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AJIRB-MED-MDB-18-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No