Sugammadex Titration in Cardiac Surgery Patients

NCT05246397 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00013925
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade. Clinical studies and experience have suggested that smaller doses may be effective. The purpose of this observational study is to determine the minimal effective dose of sugammadex by administering 50 mg every 5 minutes until the train-of-four ratio is 0.9 in a cohort of cardiac surgery patients, and to determine the duration of action by measuring the train-of-four every hour for up to 6 hours following reversal.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Aorta Disease; Heart Failure

Keywords

neuromuscular blockade; sugammadex; monitoring; rocuronium; vecuronium

Outcome Measures

Primary Outcomes (2)

• Total Dose of Sugammadex Required to Produce a Train-of-four Ratio of >0.9, Categorized as Greater Than or Less Than the Manufacturers Recommended Dose Based on the Train-of-four or Post Tetanic Response Prior to Administration of Sugammadex

  Sugammadex will be administered in 50 mg increments every 5 minutes until a train-of-four ratio of at least 0.9 is reached. The total dose of sugammadex for each patient will be categorized as greater than or less than the manufacturers recommended dose

  At the completion of surgery and prior to transport to the intensive care unit. The elapsed time from completion of surgery to arrival in the intensive care unit is 30 min to 1 hour

• Duration of Action of Reversal

  The train-of-four ratio will be determined upon arrival to the ICU and every hour for 6 hours or until extubation (whichever is less) and categorized as remaining greater than or equal of 0.9, or declining to \<0.9 (described as "recurrent" neuromuscular blockade)

  On arrival to the intensive care unit and hourly thereafter for 6 hours or until extubation, whichever occurs first

Study Arms (1)

Cardiac surgery patients

EXPERIMENTAL

Patients undergoing cardiac surgery

Drug: Sugammadex administration

Interventions

Sugammadex administration DRUG

Sugammadex will be given in 50 mg increments every five minutes for reversal of neuromuscular blockade until reaching a train-of-four ratio of 0.9

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cardiac surgery patients

You may not qualify if:

• Allergic or other adverse response to sugammadex

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Aortic Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Andrew Bowdle MD, PhD, FASE
• Organization: University of Washington

bowdle@u.washington.edu

206-979-0477

Study Officials

• T. Andrew Bowdle, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: February 18, 2022
• Study Start: February 1, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)