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Neostigmine/Glycopyrrolate for Coronary Artery Disease
Phase 4
Waitlist Available
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 - 70 years
American Society of Anesthesiology physical status I-4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-60 minutes post-extubation
Awards & highlights
Study Summary
This trial is testing if Sugammadex will help reduce time from anesthesia reversal to extubation, and improve other post-extubation outcomes, in patients who have had coronary artery bypass surgery.
Eligible Conditions
- Coronary Artery Disease
- Surgery
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-60 minutes post-extubation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-60 minutes post-extubation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Extubation
Secondary outcome measures
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
Heart Rate
Peak Flow Rate
+2 moreOther outcome measures
Length of Stay Cardiac Intensive Care Unit
Occurrence of Postoperative Cardiac Complications
Occurrence of Postoperative Respiratory Complications
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Neostigmine/GlycopyrrolateActive Control3 Interventions
Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage).
Group II: SugammadexActive Control2 Interventions
Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).
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Who is running the clinical trial?
West Virginia UniversityLead Sponsor
174 Previous Clinical Trials
56,122 Total Patients Enrolled
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