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Cholinesterase Inhibitor
Reversal Agents for Postoperative Urinary Retention
Phase 4
Recruiting
Led By Kurt Ruetzler, MD
Research Sponsored by The Cleveland Clinic
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 end surgery to discharge
Awards & highlights
Study Summary
This trial will compare the effects of two drugs used to reverse muscle paralysis after surgery.
Who is the study for?
This trial is for adults aged 65 or older who are having noncardiac surgery under general anesthesia with muscle relaxation, and will stay in the hospital overnight. They must be healthy enough (ASA status 1-3) and able to consent. People with urinary issues, severe liver or kidney disease, neurological conditions, or those on certain medications can't join.Check my eligibility
What is being tested?
The study compares two drugs used to reverse muscle relaxation after surgery: Sugammadex and Neostigmine combined with glycopyrrolate. It's a randomized trial for patients given rocuronium or vecuronium during their procedure.See study design
What are the potential side effects?
Possible side effects include allergic reactions, changes in heart rate or blood pressure from Neostigmine/glycopyrrolate; Sugammadex may cause minor symptoms like nausea or headache but also has potential for serious allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Retention
Secondary outcome measures
Complications related to urinary retention
Other outcome measures
Post -void urine
Trial Design
2Treatment groups
Active Control
Group I: NeostigmineActive Control1 Intervention
Reversal of Neuromuscular Block by Neostigmine.
Group II: SugammadexActive Control1 Intervention
Reversal of Neuromuscular Block by Sugammadex.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,027 Previous Clinical Trials
1,365,882 Total Patients Enrolled
1 Trials studying Neuromuscular Blockade
69 Patients Enrolled for Neuromuscular Blockade
Kurt Ruetzler, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
13,574 Total Patients Enrolled
Daniel I Sessler, MDStudy ChairThe Cleveland Clinic
33 Previous Clinical Trials
97,002 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled to have a urinary catheter placed during surgery.I will have a catheter placed before surgery.I am 65 years old or older.I have had bladder cancer in the past.I have a urinary tract infection or other bladder-related health issues.I will be given medication to reverse muscle relaxation after surgery.I have a neurological condition like Alzheimer's, stroke, or MS.I am not allergic or sensitive to the drugs being tested in this study.I am scheduled to stay in the ICU after my surgery.My overall health is good to moderately impaired.I am an adult scheduled for a non-heart surgery lasting 2 hours or more.I have not had recent major surgery in my brain, abdomen, or urinary system.I am currently taking medications like antihistamines or antidepressants.I have severe liver or kidney problems.I will be under general anesthesia with specific muscle relaxants for my procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Neostigmine
- Group 2: Sugammadex
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 this research begun to accept participants yet?
"Clinicaltrials.gov reports that this medicinal trial is no longer actively recruiting, with the initial posting being on October 1st 2022 and the last update occurring 6 days later. Nonetheless, there are 297 other studies currently open to participants at present."
Answered by AI
What potential consequences should individuals be aware of before utilizing Reversal of Neuromuscular?
"Reversal of Neuromuscular has been authorized, thus making it eligible for a safety rating of 3 according to our team's evaluation at Power."
Answered by AI
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