Sugammadex for Respiratory Complications

Overseen By Stephanie-Dee Sarovich, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Must be taking: Sugammadex

Disqualifiers: Age under 18, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

13000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to: 1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. 2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.

Eligibility Criteria

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.

Inclusion Criteria

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 been given sugammadex from the study's designated supply.

Exclusion Criteria

You are still using a breathing tube or have a tracheostomy after surgery.

You have a known neuromuscular disease.

Patients under the age of 18

Timeline

Retrospective Data Analysis

Analysis of data from the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction before and after the introduction of sugammadex.

6 months

Pathway Design and Implementation

Design and implementation of a clinical best practice pathway to prevent postoperative respiratory complications using clinical decision support.

6 months

Prospective Data Collection

Data collection during the implementation of the pathway to monitor the application of best practices and outcomes.

1 year

Follow-up

Participants are monitored for safety and effectiveness after pathway implementation.

1 year

Treatment Details

Interventions

• Sugammadex

Trial Overview 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.

Participant Groups

Group I: CDS pathway Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University