Sugammadex Titration in Cardiac Surgery Patients

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified January 2022 by University of Washington
Sponsor
University of Washington
Information Provided by (Responsible Party)
T. Andrew Bowdle
Clinicaltrials.gov Identifier
NCT05246397
Other Study ID Numbers:
STUDY00013925
First Submitted
September 22, 2021
First Posted
February 17, 2022
Results First Posted
September 17, 2023
Last Update Posted
March 20, 2024
Last Verified
January 2022

ClinicalTrials.gov processed this data on March 2024Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Neuromuscular blocking drugs are used frequently during general anesthesia. The effects of neuromuscular blocking drugs are measured using a twitch monitor, that stimulates the ulnar nerve and measures the evoked response of the adductor pollicis muscle (thumb flexion), or other intrinsic hand muscle. When a series of 4 twitches is administered, the ratio of the first to the fourth twitch (train-of-four ratio) may be used to gauge the degree of muscle relaxation. A train-of-four ratio of 0.9 or greater is considered to represent adequate recovery from neuromuscular blockade. At the end of surgery, antagonists of neuromuscular blockade are commonly administered to reverse any remaining muscle relaxation. Sugammadex is a highly effective reversal agent of the aminosteroid neuromuscular blockings drugs rocuronium and vecuronium, which are the most commonly used neuromuscular blocking drugs. The recommended dose of sugammadex depends upon the degree of neuromuscular blockade. When at least 1 twitch of the train-of-four is present, the recommended dose of sugammadex is 2 mg/kg. When there are no twitches of the train-of-four present, but at least 1 count of the post tetanic count is present, the recommended dose of sugammadex is 4 mg/kg. However, in several dose ranging studies of sugammadex, and in using sugammadex clinically, we and others have determined that smaller doses of sugammadex, often much less than 2 mg/kg, may be effective producing a train-of-four ratio of 0.9 or greater. Sugammadex binds (encapsulates) aminosteroid neuromuscular blocking drugs tightly and the sugammadex-aminosteroid complex is subsequently cleared by the kidney. Therefore we do not expect that recurrence of neuromuscular blockade would occur, even after small doses of sugammadex, as long as the dose of sugammadex is adequate to produce a train-of-four ratio of 0.9. However, additional studies are needed to confirm that recurrence of neuromuscular blockade does not occur after small doses of sugammadex. The purpose of the proposed study is to test the hypothesis that when sugammadex is titrated in 50 mg increments until the train-of-four ratio is 0.9 or greater, that this train-of-four ratio is maintained and there is no recurrence of neuromuscular blockade.

Neuromuscular blockade will be monitored with EMG (electromyography)-based quantitative twitch monitoring (TwitchView). At the end of cardiac surgery, sugammadex will be administered to reverse neuromuscular blockade, as defined by a train-of-four ratio of 0.9 or greater. The patient will then transported asleep, intubated and ventilated to the intensive care unit where the train-of-four ratio of 0.9 or greater will be confirmed on arrival by the respiratory therapist.

Instead of administering a standard dose of sugammadex 2 mg/kg or 4 mg/kg, sugammadex will be titrated in 50 mg increments every 5 minutes until a train-of-four ratio of 0.9 or greater is reached. Train-of-four ratio will be measured on arrival in the intensive care unit and then hourly for 6 hours or until extubation if extubation occurs in \<6 hours. If the train-of-four ratio is less than 0.9 at any time, additional sugammadex will be administered until the train-of-four ratio is 0.9 or greater. The twitch monitoring results in the operating room just prior to reversal, following reversal and hourly in the intensive care unit will be recorded, along with sugammadex doses. The total dose of rocuronium or vecuronium and the time period of neuromuscular blocking drug will also be recorded. Data will either be recorded in real time by study assistants or retrieved from the electronic medical record. The patient's age, gender, and weight will be recorded.

Condition or DiseaseIntervention/Treatment
Coronary Artery DiseaseValvular Heart DiseaseAorta DiseaseHeart Failure
Drug: Sugammadex administration

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeOther
Official TitleSugammadex Titration for Reversal of Rocuronium or Vecuronium in Cardiac Surgery Patients
Study Start DateJanuary 31, 2022
Actual Primary Completion DateNovember 9, 2022
Actual Study Completion DateNovember 9, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Cardiac surgery patients
Patients undergoing cardiac surgery
Drug: Sugammadex administration
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

Outcome Measures

Primary Outcome Measures
  1. 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
  2. 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 \&lt;0.9 (described as &quot;recurrent&quot; neuromuscular blockade)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria
All cardiac surgery patients
Exclusion Criteria
Allergic or other adverse response to sugammadex

Contacts and Locations

Sponsors and CollaboratorsUniversity of Washington
Locations
University of Washington Medical Center | Seattle Washington, United States, 98195
Investigators
Principal Investigator: T. Andrew Bowdle, MD, PhD, University of Washington
Study Documents (Full Text)
Documents provided by University of WashingtonStudy Protocol and Statistical Analysis Plan  April 21, 2022