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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03939923

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted June 30, 2020

Study Description

Brief summary:

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).

  • Condition or Disease:Surgery
    Coronary Artery Disease
  • Intervention/Treatment: Drug: Rocuronium
    Drug: Neostigmine
    Drug: Glycopyrrolate
    Drug: Sugammadex
  • Phase: Phase 4
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 84 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention 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 (Care Provider)
  • Primary Purpose: Treatment
  • Official Title: Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Group One
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 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
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.

Drug: Neostigmine
Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)

Drug: Glycopyrrolate
Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
Active Comparator: Group Two
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 TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).
Drug: Rocuronium
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.

Drug: Sugammadex
Reversal with Sugammadex (2mg/kg)
Outcome Measures
  • Primary Outcome Measures: 1. Time to Extubation [ Time Frame: at 0 minutes of study drug to 3 days after study drug administration ]
    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".
  • Secondary Outcome Measures: 1. Heart rate [ Time Frame: at 0 mintues to 2 hours after study drug administration ]
    Heart rate post-reversal prior to extubation
  • 2. Blood Pressure [ Time Frame: at 0 mintues to 2 hours after study drug administration ]
    Blood pressure post-reversal prior to extubation, both systolic and diastolic
  • 3. Tidal Volume [ Time Frame: between 30 minutes to 1 hour after extubation ]
    Tidal volume post-reversal prior to extubation
  • 4. Peak Flow Rate [ Time Frame: 30-60 minutes post-extubation ]
    Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
  • 5. Swallowing Capacity [ Time Frame: 30-60 minutes post-extubation ]
    Swallowing capacity measured by Functional Dysphagia screen administered at 30 - 60 mins post extubation.
  • Other Outcome Measures: 1. Occurrence of Postoperative Cardiac Complications [ Time Frame: from 0 hours after study drug to 2 hours after study drug ]
    Postoperative cardiac complications.
  • 2. Oxygen Saturation [ Time Frame: 2 hours post-extubation every 15 minutes ]
    Oxygen saturation post-extubation for subsequent 2 hours documented every 15 minutes
  • 3. Post-extubation Oxygen Requirements [ Time Frame: 2 hours post-extubation ]
    Post-extubation Oxygen requirements in subsequent 2 hours
  • 4. Length of Stay cardiac intensive care unit [ Time Frame: 0 days after study drug to 100 days after study drug ]
    Length of stay in the cardiac intensive care from onset of reversal drugs
  • 5. Reintubation Incidence [ Time Frame: 24 hours post-extubation ]
    Reintubation incidence in the first 24 hours post-extubation
  • 6. Occurrence of Postoperative Respiratory Complications [ Time Frame: 0 hours after study drug to 24 hours after study drug ]
    Postoperative respiratory complication
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Age 18 - 70 years

- American Society of Anesthesiology physical status I-4

- Isolated coronary artery bypass graft surgery

- 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

Contacts and Locations
Contacts

Contact: Matthew Ellison, MD 304-598-4929 mellison@wvumedicine.org

Contact: Connie Tennant, RN, CCRP 304-598-6193 cstennant@wvumedicine.org

Locations

United States, West Virginia
WVU Medicine
Morgantown

Sponsors and Collaborators

West Virginia University

More Information