The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

NCT ID: NCT03619759

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 585 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-22
• Study Completion Date: 2018-09-01

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).

Conditions

Outcome, Fatal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Sugammadex

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

Sugammadex

Intervention Type: DRUG

Sugammadex injection as a reverse agent of neuromuscular blocking

Non-sugammadex

Patients who didn't use sugammadex Pyridostigmine 15\~20mg intravenous, at the end of surgery, before extubation

No interventions assigned to this group

Interventions

Sugammadex

Sugammadex injection as a reverse agent of neuromuscular blocking

Intervention Type: DRUG

Other Intervention Names

Bridion

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

In-kyong Yi

Clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Kyong Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou university school of medicine

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-MDB-18-36

Identifier Type: -

Identifier Source: org_study_id