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Sugammadex vs Neostigmine for Neuromuscular Blockade
N/A
Recruiting
Led By Ryu Komatsu, 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
American Society of Anesthesiologist physical status 3-4
Scheduled for outpatient endoscopic retrograde cholangiopancreatography
Must not have
Neuromuscular Disorders (eg: ALS, Botulism, Myasthenia Gravis, Lambert-eaton syndrome)
End stage renal disease requiring dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 24 hours after reversal of neuromuscular block
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two different drugs used to reverse muscle relaxation in patients undergoing a specific type of procedure at Cleveland Clinic Main Campus.
Who is the study for?
This trial is for adults over 18 who are in moderate to severe physical condition (ASA status 3-4) and scheduled for an outpatient procedure called endoscopic retrograde cholangiopancreatography at Cleveland Clinic Main Campus.
What is being tested?
The study compares two drugs, sugammadex and neostigmine, to see which one is better at reversing muscle relaxation caused by rocuronium during the specified medical procedure. Participants will be randomly assigned to receive either drug without knowing which one they get.
What are the potential side effects?
Possible side effects of sugammadex include allergic reactions, changes in heart rate or blood pressure, while neostigmine can cause nausea, vomiting, slowed heart rate, and other digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a serious but not life-threatening illness.
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I am scheduled for an ERCP procedure.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neuromuscular disorder like ALS or Myasthenia Gravis.
Select...
I am on dialysis for end-stage kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 24 hours after reversal of neuromuscular block
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 24 hours after reversal of neuromuscular block
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time required from reversal of neuromuscular block to discharge readiness
Secondary study objectives
Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 2 mg/kg sugammadexExperimental Treatment1 Intervention
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex.
Group II: 0.07 mg/kg neostigmineActive Control1 Intervention
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg).
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,636 Total Patients Enrolled
36 Trials studying Neuromuscular Blockade
42,702 Patients Enrolled for Neuromuscular Blockade
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,392 Total Patients Enrolled
2 Trials studying Neuromuscular Blockade
355 Patients Enrolled for Neuromuscular Blockade
Ryu Komatsu, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
8 Total Patients Enrolled