Outcome, FatalSugammadexNCT03619759
The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
An observational study of Outcome, Fatal, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Outcome, Fatal
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- How many people
- 585 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2018to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer from Jan, 2012 to Dec, 2017
Who may be able to join
- Subjects aged 21~80
- Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017
Who cannot join
- Emergency surgery
- Paraplegia or quadriplegia
- Bedridden state d/t various reason
- Neuromuscular disease
- Combined operation wth other surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16377
About this study
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.
Read the 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
- Being tested
- Sugammadex
- Keywords
- Sugammadex, Colorectal surgery, postoperative complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Sugammadex injection as a reverse agent of neuromuscular blocking
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation Receives: Drug: Sugammadex | |
| Non-sugammadex | Patients who didn't use sugammadex Pyridostigmine 15~20mg intravenous, at the end of surgery, before extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of stay in hospital
Measured: admission to discharge (within 1 month)
Secondary outcomes (3)
Readmission rate
Readmission or ER visit within 30 days after discharge
Measured: 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
Measured: after colorectal surgery, within 30 days
Time to first successful oral intake
time interval between end of surgery and the first successful oral intake
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start22 Mar 2018
- Primary completion31 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, FatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619759
- Sponsor's protocol ID
- AJIRB-MED-MDB-18-36
- Acronym
- Sugammadex
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03619759
- Acronym / sponsor ID
- Sugammadex / AJIRB-MED-MDB-18-36
- Conditions
- Outcome, Fatal
- Keywords
- Sugammadex, Colorectal surgery, postoperative complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | – | Drug: SugammadexPatients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation |
| Non-sugammadex | – | –Patients who didn't use sugammadex Pyridostigmine 15~20mg intravenous, at the end of surgery, before extubation |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer from Jan, 2012 to Dec, 2017
Key inclusion criteria (2 listed)
- Subjects aged 21~80
- Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017
Key exclusion criteria (5 listed)
- Emergency surgery
- Paraplegia or quadriplegia
- Bedridden state d/t various reason
- Neuromuscular disease
- Combined operation wth other surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: BridionSugammadex injection as a reverse agent of neuromuscular blocking | Drug | Sugammadex |
Primary outcome
Length of stay
Time frame: admission to discharge (within 1 month)
Length of stay in hospital
3 secondary outcomes
Readmission rate
Time frame: 30 days after discharge
postoperative complication rate
Time frame: after colorectal surgery, within 30 days
Time to first successful oral intake
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No. No sharing
Related trials for Outcome, Fatal
Active, not recruitingObservational study
Nut Consumption and Prevention of Non-communicable Diseases: A Global Individual Participant Data Meta-analysis
Diabetes (DM), Cardio Vascular Disease
RecruitingObservational study
Russian Registry of Surgical OutcomeS
Surgery, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, Fatal, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: admission to discharge (within 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.