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

Study Overview
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Brief Summary
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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).

Detailed Description
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Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures . To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.

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

Conditions
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Surgery, Coronary Artery Disease

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Neostigmine
* Drug: Glycopyrrolate
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage). Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine/Glycopyrrolate<br>Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). | Drug: Rocuronium<br>* Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.<br>Drug: Neostigmine<br>* Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)<br>Drug: Glycopyrrolate<br>* Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)<br>|
| Active Comparator: Sugammadex<br>Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). | Drug: Rocuronium<br>* Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.<br>Drug: Sugammadex<br>* Reversal with Sugammadex (2mg/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Extubation | Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart procedure stop. The definition for time to extubation is from the time the investigators chart procedure stop to the time of extubation. | 0 minutes of study drug to 3 days after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate post-reversal prior to extubation | 0 minutes to 2 hours after study drug administration | 
| Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal) | Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea | 0 minutes to 2 hours after study drug administration | 
| Tidal Volume | Tidal volume post-reversal prior to extubation | between 30 minutes to 1 hour after extubation | 
| Peak Flow Rate | Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins | 30-60 minutes post-extubation | 
| Swallowing Capacity | In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking. | Between 30 and 60 minutes post-extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting Surgery, Sugammadex