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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 below

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People 18 years or older who had surgery at UCLA Ronald Reagan or Santa Monica and were given a certain type of anesthesia.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year prior to study intervention to one year following implementation of study intervention for reporting.

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 more

Trial 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

0 / 2Eligibility criteria met