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Trial record 69 of 188 for:    GLYCOPYRROLATE

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

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ClinicalTrials.gov Identifier: NCT03939923
Recruitment Status : Active, not recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Ellison, West Virginia University

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 Intervention/treatment Phase
Surgery Coronary Artery Disease Drug: Rocuronium Drug: Neostigmine Drug: Glycopyrrolate Drug: Sugammadex 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.


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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
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 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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)




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. Oxygen Saturation [ Time Frame: 2 hours post-extubation every 15 minutes ]
    Oxygen saturation post-extubation for subsequent 2 hours documented every 15 minutes

  2. Post-extubation Oxygen Requirements [ Time Frame: 2 hours post-extubation ]
    Post-extubation Oxygen requirements in subsequent 2 hours

  3. 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

  4. Reintubation Incidence [ Time Frame: 24 hours post-extubation ]
    Reintubation incidence in the first 24 hours post-extubation

  5. Occurrence of Postoperative Respiratory Complications [ Time Frame: 0 hours after study drug to 24 hours after study drug ]
    Postoperative respiratory complication

  6. Occurrence of Postoperative Cardiac Complications [ Time Frame: from 0 hours after study drug to 2 hours after study drug ]
    Postoperative cardiac complications.



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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939923


Locations
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United States, West Virginia
WVU Medicine
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University

Publications:

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Responsible Party: Matthew Ellison, Co-Director Cardiovascular Anesthesiology, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03939923     History of Changes
Other Study ID Numbers: WVU Protocol #: 1806161309
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Matthew Ellison, West Virginia University:
Coronary Artery Bypass Grafting Surgery
Sugammadex
Additional relevant MeSH terms:
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Glycopyrrolate
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists