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Sugammadex for Intestinal Obstruction
Phase 4
Recruiting
Led By Clayton C Petro, MD
Research Sponsored by Clayton Petro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after randomization
Awards & highlights
Study Summary
This trial tests if sugammadex can speed up time to return of bowel function after open abdominal surgery.
Who is the study for?
This trial is for adults over 18 needing non-emergency open ventral hernia repair with specific conditions. Eligible participants should not have severe kidney or liver failure, be at risk of small bowel obstruction as judged by the surgeon, use certain drugs affecting liver enzymes, have a history of chronic opioid use, or disorders that compromise the gastrointestinal lining. Pregnant or breastfeeding individuals and those unable to consent are excluded.Check my eligibility
What is being tested?
The study compares sugammadex with standard care (neostigmine/glycopyrrolate) in speeding up the return of bowel function after neuromuscular blockade reversal in abdominal wall reconstruction surgery. It aims to see if sugammadex can improve recovery times for patients undergoing this procedure.See study design
What are the potential side effects?
Sugammadex may cause side effects like allergic reactions, changes in heart rate, blood pressure variations, and nausea. Neostigmine/Glycopyrrolate could lead to vision issues, dry mouth, difficulty urinating and heart rhythm changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to GI-2 bowel function after surgery
Secondary outcome measures
Length of stay
Opioid used in morphine milligram equivalents
Postoperative complications
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: SugammadexExperimental Treatment1 Intervention
Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches
Group II: Neostigmine/GlycopyrrolateExperimental Treatment1 Intervention
Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410
Find a Location
Who is running the clinical trial?
Clayton PetroLead Sponsor
4 Previous Clinical Trials
1,448 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,374 Total Patients Enrolled
Clayton C Petro, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
1,006 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known small bowel obstruction at the time of my hernia repair.I have severe kidney problems.I am over 18 years old.I am not taking strong or moderate drugs that affect liver enzymes.I have a stoma.My doctor has advised against using sugammadex for me.My surgical mesh repair is not behind the muscle.I cannot be safely removed from a breathing machine after surgery.My cancer increases the risk of holes in my stomach or upper intestine.I need an urgent surgery.My liver is not working well (severe issues).I have a tube placed in my stomach for feeding that will remain after my hernia surgery.My brain's protective barrier is not functioning properly.I have a hernia with a gap larger than 20cm.I am having or had a surgery with small cuts.I am at risk of or currently have a suspected small bowel obstruction.My hernia's gap is less than 20cm wide.I have significant liver problems.I have a condition that affects my stomach or intestine lining.I need an open hernia repair with a specific technique and muscle flap.
Research Study Groups:
This trial has the following groups:- Group 1: Neostigmine/Glycopyrrolate
- Group 2: Sugammadex
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Neostigmine / Glycopyrrolate for medical use?
"The safety of Neostigmine/Glycopyrrolate has been sufficiently demonstrated in prior clinical trials and is thus rated a 3. This medication has already received approval for use by government health organisations."
Answered by AI
Is enrollment in this trial still open for participation?
"The study's online portal on clinicaltrials.gov reveals that this particular trial is no longer recruiting candidates, as the posting date and last edited dates are 9/1/2023 and 8/8/2023 respectively. Nevertheless, there remain 52 trials still looking for suitable participants at present."
Answered by AI
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