Skip to main content
OpenTrials
Completed

NCT Number: NCT03939923

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

WVU Medicine

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

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.

Neostigmine

Drug

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

Glycopyrrolate

Drug

Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)

Sugammadex

Drug

Reversal with Sugammadex (2mg/kg)

Primary outcomes

  1. Time to Extubation

    Time frame: 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 outcomes

  1. Heart Rate

    Time frame: 0 minutes to 2 hours after study drug administration

    Heart rate post-reversal prior to extubation

  2. Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)

    Time frame: 0 minutes to 2 hours after study drug administration

    Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea

  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: Between 30 and 60 minutes post-extubation

    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.

Other outcomes

  1. Oxygen Saturation

    Time frame: 30 minutes post-extubation

    Oxygen saturation post-extubation

  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 including re-intubation

  6. Occurrence of Postoperative Cardiac Complications

    Time frame: from 0 hours after study drug to 2 hours after study drug

    Postoperative cardiac complications including myocardial infarction, arrythmias

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 7, 2019
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.