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

Sponsor

West Virginia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03939923

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	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.

Study Design

Study Type:

Interventional

Actual 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.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

Actual Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Dec 1, 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)

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

Time to Extubation [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

Heart rate [at 0 mintues to 2 hours after study drug administration]
Heart rate post-reversal prior to extubation
Blood Pressure [at 0 mintues to 2 hours after study drug administration]
Blood pressure post-reversal prior to extubation, both systolic and diastolic
Tidal Volume [between 30 minutes to 1 hour after extubation]
Tidal volume post-reversal prior to extubation
Peak Flow Rate [30-60 minutes post-extubation]
Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
Swallowing Capacity [30-60 minutes post-extubation]
Swallowing capacity measured by Functional Dysphagia screen administered at 30 - 60 mins post extubation.

Other Outcome Measures

Oxygen Saturation [2 hours post-extubation every 15 minutes]
Oxygen saturation post-extubation for subsequent 2 hours documented every 15 minutes
Post-extubation Oxygen Requirements [2 hours post-extubation]
Post-extubation Oxygen requirements in subsequent 2 hours
Length of Stay cardiac intensive care unit [0 days after study drug to 100 days after study drug]
Length of stay in the cardiac intensive care from onset of reversal drugs
Reintubation Incidence [24 hours post-extubation]
Reintubation incidence in the first 24 hours post-extubation
Occurrence of Postoperative Respiratory Complications [0 hours after study drug to 24 hours after study drug]
Postoperative respiratory complication
Occurrence of Postoperative Cardiac Complications [from 0 hours after study drug to 2 hours after study drug]
Postoperative cardiac complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	WVU Medicine	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

West Virginia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Matthew Ellison, Co-Director Cardiovascular Anesthesiology, Associate Professor, West Virginia University

ClinicalTrials.gov Identifier:

NCT03939923

Other Study ID Numbers:

WVU Protocol #: 1806161309

First Posted:

May 7, 2019

Last Update Posted:

Aug 6, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Matthew Ellison, Co-Director Cardiovascular Anesthesiology, Associate Professor, West Virginia University

Coronary Artery Bypass Grafting Surgery

Sugammadex

Additional relevant MeSH terms:

Coronary Artery Disease

Glycopyrrolate

Rocuronium

Neostigmine

Study Results

No Results Posted as of Aug 6, 2021