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Selective Relaxant Binding Agent

Sugammadex for Improved Bowel Function After Surgery (STIM_Bowel Trial)

Phase 4
Waitlist Available
Led By Brandon M Togioka, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned general endotracheal anesthesia
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after the administration of reversal drug.
Awards & highlights

STIM_Bowel Trial Summary

This trial will compare the effects of two drugs given to reverse paralysis after surgery - one has no effect on bowel function, while the other does.

Who is the study for?
This trial is for adults over 18 who are having colorectal surgery at Oregon Health & Science University, scheduled Monday to Friday with planned general anesthesia. It's not for those allergic to study drugs, on Toremifene, prisoners, unable to consent, with severe kidney or liver issues, pregnant women, or if neuromuscular blockade is medically contraindicated.Check my eligibility
What is being tested?
The trial tests whether Sugammadex improves bowel function after colorectal surgery compared to the standard reversal agents glycopyrrolate and neostigmine. The goal is to see if Sugammadex leads to faster gastric emptying and fewer postoperative complications.See study design
What are the potential side effects?
Sugammadex may cause minor side effects like nausea or pain at the injection site. Neostigmine can lead to slowed heart rate and digestive disturbances. Side effects vary by individual.

STIM_Bowel Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery with general anesthesia through a breathing tube.
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I am 18 years old or older.
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My surgery is scheduled in the South Operating Rooms at OHSU.
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My surgery is planned for a weekday.
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I am scheduled for or have had colorectal surgery.

STIM_Bowel Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after the administration of reversal drug.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after the administration of reversal drug. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gastric emptying
Secondary outcome measures
Time in minutes to reach train of four (TOF) ratio ≥ 0.9 after the administration of reversal drug.
Other outcome measures
Bowel movement
Gastrointestinal complications
Hospital length of stay
+1 more

STIM_Bowel Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SugammadexExperimental Treatment1 Intervention
Sugammadex 2 mg/kg IV once at the end of surgery
Group II: NeostigmineActive Control1 Intervention
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
FDA approved

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
966 Previous Clinical Trials
6,845,631 Total Patients Enrolled
2 Trials studying Postoperative Complications
202 Patients Enrolled for Postoperative Complications
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,612 Total Patients Enrolled
5 Trials studying Postoperative Complications
893 Patients Enrolled for Postoperative Complications
Brandon M Togioka, MDPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
7 Previous Clinical Trials
932 Total Patients Enrolled
1 Trials studying Postoperative Complications
200 Patients Enrolled for Postoperative Complications

Media Library

Sugammadex (Selective Relaxant Binding Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04546672 — Phase 4
Postoperative Complications Research Study Groups: Sugammadex, Neostigmine
Postoperative Complications Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT04546672 — Phase 4
Sugammadex (Selective Relaxant Binding Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04546672 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participants in this clinical research?

"Correct. According to clinicaltrials.gov, this medical experiment which was initially posted on March 16th 2021 is still in the process of seeking patient volunteers. 1 centre requires 120 people for participation purposes. The details were most recently amended on September 22nd 2022."

Answered by AI

What maladies are typically alleviated by Sugammadex?

"Sugammadex is a viable solution for the resolution of neuromuscular blockade, post-operative intestinal atony, and denture retention."

Answered by AI

Has the FDA sanctioned Sugammadex for medical applications?

"The safety rating of Sugammadex received a score of 3 as it has been tested and approved for use in Phase 4 trials."

Answered by AI

Are enrollment opportunities still available for this research study?

"Affirmative. According to the information on clinicaltrials.gov, this trial is actively enrolling participants with an original post date of March 16th 2021 and most recent update from September 22nd 2022. A total of 120 patients are being accepted at a single medical facility."

Answered by AI

Are there any preexisting studies that demonstrate the efficacy of Sugammadex?

"Presently, 15 ongoing investigations are examining the efficacy of sugammadex with 1 in Phase 3. Not only is Rochester, Minnesota running trials for Sugammadex but 51 sites across the nation have opened up studies as well."

Answered by AI
~30 spots leftby Mar 2025