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Sugammadex for Respiratory Complications
Phase 4
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium
Patients who receive sugammadex from the specified study supply
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year prior to study intervention to one year following implementation of study intervention
Awards & highlights
Study Summary
This trial will look at whether sugammadex can help prevent respiratory problems after surgery in people who are at high risk for these complications.
Who is the study for?
This trial is for adult patients at UCLA hospitals who've had general anesthesia with specific muscle relaxants and received sugammadex. It excludes those under 18, with neuromuscular diseases, known drug allergies, severe kidney issues or who remained intubated after surgery.Check my eligibility
What is being tested?
The study analyzes past data to see if respiratory problems in the recovery room decreased after sugammadex was used. It also tests a new best practice pathway using education and decision support to prevent breathing complications in high-risk patients.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of sugammadex may include nausea, vomiting, headache, pain or reactions at the injection site. Serious allergic reactions are rare but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
People 18 years or older who had surgery at UCLA Ronald Reagan or Santa Monica and were given a certain type of anesthesia.
Select...
You have been given sugammadex from the study's designated supply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year prior to study intervention to one year following implementation of study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year prior to study intervention to one year following implementation of study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of hypoxemia in the PACU (oxygen saturation below 90%)
Time to "fitness for discharge" from the recovery room
Secondary outcome measures
Duration of supplemental oxygen needed by high-risk patients
Oxygen Saturation
Number of patients with unplanned upgrade of care
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CDS pathwayExperimental Treatment1 Intervention
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex 100 MG/ML [Bridion]
2023
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,526 Previous Clinical Trials
10,262,904 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,883 Previous Clinical Trials
5,040,936 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are still using a breathing tube or have a tracheostomy after surgery.People 18 years or older who had surgery at UCLA Ronald Reagan or Santa Monica and were given a certain type of anesthesia.You have a known neuromuscular disease.You have been given sugammadex from the study's designated supply.You are allergic to rocuronium, vecuronium, sugammadex, neostigmine, or glycopyrrolate.Your kidneys are not working well, with a filtration rate lower than 30, or you are undergoing hemodialysis.You have not been given medication to reverse the effects of muscle relaxants before or after the study.
Research Study Groups:
This trial has the following groups:- Group 1: CDS pathway
Awards:
This trial has 3 awards, including:- 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.
- 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.
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