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Sugammadex for Cardiac Surgery Outcomes

Phase 3
Recruiting
Led By Steven Greenberg, MD
Research Sponsored by NorthShore University HealthSystem
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 168 hours (7days)
Awards & highlights

Study Summary

This trial will compare 2 groups of cardiac surgical patients to see which drug leads to better outcomes after surgery.

Who is the study for?
This trial is for men and women aged 21-90 undergoing elective or urgent heart surgery with cardiopulmonary bypass at NorthShore University HealthSystem. They must be able to consent in English and be candidates for fast track extubation, which means they're expected to have their breathing tube removed within 24 hours after surgery.Check my eligibility
What is being tested?
The study compares the effects of Sugammadex, a drug used to reverse muscle relaxation from anesthesia, versus a placebo in patients after cardiac surgery. It will assess how quickly patients can have their breathing tubes removed, length of ICU/hospital stay, costs, pneumonia development, re-intubation rates, and nurse perceptions of recovery.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Sugammadex may include nausea, vomiting, headache, mild allergic reactions or itching. Placebo typically has no active ingredients but can cause similar symptoms due to patient expectations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative (the time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative (the time (in hours) it takes to remove the breathing tube immediately at the end of surgery.) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Society of Thoracic Surgery (STS) quality benchmark of early extubation criteria
Secondary outcome measures
Cost of ICU Stay
Hospital length of stay
ICU length of stay
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SugammadexExperimental Treatment1 Intervention
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Group II: PlaceboPlacebo Group1 Intervention
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
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?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,483 Total Patients Enrolled
1 Trials studying Surgery
22 Patients Enrolled for Surgery
Steven Greenberg, MDPrincipal InvestigatorNorthShore University HealthSystem
3 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05801679 — Phase 3
Surgery Research Study Groups: Sugammadex, Placebo
Surgery Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05801679 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05801679 — Phase 3
Surgery Patient Testimony for trial: Trial Name: NCT05801679 — Phase 3

Frequently Asked Questions

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

Are participants of the trial restricted to adults over eighteen years old?

"This trial is recruiting participants aged 21 or older, with a maximum age limit of 90."

Answered by AI

Are there still open slots in this research project for participants?

"This research study, as seen on clinicaltrials.gov, is presently enrolling participants; it was initially advertised on the 3rd of July 2023 and updated most recently on 11th July 2023."

Answered by AI

What is the current enrollment rate of this clinical trial?

"Affirmative. The trial, which was unveiled on July 3rd 2023, is actively recruiting according to clinicaltrials.gov data. 175 participants are needed at a single site for the study to be successful."

Answered by AI

Has the FDA sanctioned Sugammadex for public use?

"There is ample clinical evidence in support of Sugammadex's safety, thus it receives a rating of 3 on our scale. This drug has gone through multiple efficacy and safety trials prior to being approved for Phase 3 testing."

Answered by AI

Are there any openings for me to join this medicinal experiment?

"This medical research endeavour is looking for 175 individuals who are 21 to 90 years old and have recently undergone surgery. Applicants must meet the following requirements: be a patient of NorthShore University HealthSystem who underwent cardiopulmonary bypass, identify as male or female, understand English and be eligible for rapid extubation (within 24 hours post-surgery)."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
NorthShore University HealthSystem
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To help others.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
Steven Greenberg 2023. "Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801679.
~103 spots leftby Jun 2025
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