Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery

Completed · Phase 4

Conditions studied: Surgery, Coronary Artery Disease

In brief

The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).

Key facts

Study ID

NCT03939923

Run by

West Virginia University

People needed

84

Starts

2019-05-01

Expected to finish

2021-07-30

Last updated by the study team

2023-12-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 - 70 years
• American Society of Anesthesiology physical status I-4
• Isolated coronary artery bypass graft surgery (CABG)
• Ability to give written informed consent

You may not qualify if…

• Any other surgical procedure concomitant to CABG surgery
• Known or suspected neuromuscular disease/pre-existing weakness
• Creatinine clearance less than 30 ml/min
• Bradycardia of less than 40 beats/min
• Pregnancy, breastfeeding women
• Known or suspected allergy to BRIDION® (sugammadex),neostigmine, or rocuronium
• Patients with contraindications towards sugammadex, neostigmine, or rocuronium
• Patients included in another trial within the last 30 days
• Patients with legal guardians or surrogate decision-making
• Female Patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex.
• Patients undergoing emergency surgery
• Patient refusal
• Patients with ejection fraction <30%
• Patients with restrictive and obstructive lung disease
• Patients with obstructive sleep apnea
• Patients with Body Mass Index greater than 40

Where it is running

• WVU Medicine — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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