The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

Outcome, Fatal Clinical Trial

— Sugammadex  

Official title:

The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619759
• Other study ID #: AJIRB-MED-MDB-18-36
• Status: Completed
• Start date: March 22, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: August 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: September 1, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Outcome, Fatal

Intervention

Drug:
• Sugammadex
Sugammadex injection as a reverse agent of neuromuscular blocking

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Length of stay in hospital	admission to discharge (within 1 month)
Secondary	Readmission rate	Readmission or ER visit within 30 days after discharge	30 days after discharge
Secondary	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
Secondary	Time to first successful oral intake	time interval between end of surgery and the first successful oral intake	within 30 days