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

Primary Purpose

Surgery, Coronary Artery Disease

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rocuronium

Neostigmine

Glycopyrrolate

Sugammadex

About this trial

This is an interventional treatment trial for Surgery focused on measuring Coronary Artery Bypass Grafting Surgery, Sugammadex

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

WVU Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group One

Group Two

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Heart rate

Heart rate post-reversal prior to extubation

Blood Pressure

Blood pressure post-reversal prior to extubation, both systolic and diastolic

Tidal Volume

Tidal volume post-reversal prior to extubation

Peak Flow Rate

Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins

Swallowing Capacity

Swallowing capacity measured by Functional Dysphagia screen administered at 30 - 60 mins post extubation.

Full Information

NCT ID

NCT03939923

First Posted

February 2, 2019

Last Updated

August 5, 2021

Sponsor

West Virginia University

1. Study Identification

Unique Protocol Identification Number

NCT03939923

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

July 30, 2021 (Actual)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West Virginia University

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgery, Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafting Surgery, Sugammadex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

Care Provider

Masking Description

The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group One

Arm Type

Active Comparator

Arm Description

Arm Title

Group Two

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rocuronium

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glycopyrrolate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Intervention Description

Reversal with Sugammadex (2mg/kg)

Primary Outcome Measure Information:

Title

Time to Extubation

Description

Time Frame

at 0 minutes of study drug to 3 days after study drug administration

Secondary Outcome Measure Information:

Title

Heart rate

Description

Heart rate post-reversal prior to extubation

Time Frame

at 0 mintues to 2 hours after study drug administration

Title

Blood Pressure

Description

Blood pressure post-reversal prior to extubation, both systolic and diastolic

Time Frame

at 0 mintues to 2 hours after study drug administration

Title

Tidal Volume

Description

Tidal volume post-reversal prior to extubation

Time Frame

between 30 minutes to 1 hour after extubation

Title

Peak Flow Rate

Description

Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins

Time Frame

30-60 minutes post-extubation

Title

Swallowing Capacity

Description

Swallowing capacity measured by Functional Dysphagia screen administered at 30 - 60 mins post extubation.

Time Frame

30-60 minutes post-extubation

Other Pre-specified Outcome Measures:

Title

Oxygen Saturation

Description

Oxygen saturation post-extubation for subsequent 2 hours documented every 15 minutes

Time Frame

2 hours post-extubation every 15 minutes

Title

Post-extubation Oxygen Requirements

Description

Post-extubation Oxygen requirements in subsequent 2 hours

Time Frame

2 hours post-extubation

Title

Length of Stay cardiac intensive care unit

Description

Length of stay in the cardiac intensive care from onset of reversal drugs

Time Frame

0 days after study drug to 100 days after study drug

Title

Reintubation Incidence

Description

Reintubation incidence in the first 24 hours post-extubation

Time Frame

24 hours post-extubation

Title

Occurrence of Postoperative Respiratory Complications

Description

Postoperative respiratory complication

Time Frame

0 hours after study drug to 24 hours after study drug

Title

Occurrence of Postoperative Cardiac Complications

Description

Postoperative cardiac complications.

Time Frame

from 0 hours after study drug to 2 hours after study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

WVU Medicine

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25173117

Citation

Badhwar V, Esper S, Brooks M, Mulukutla S, Hardison R, Mallios D, Chu D, Wei L, Subramaniam K. Extubating in the operating room after adult cardiac surgery safely improves outcomes and lowers costs. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3101-9.e1. doi: 10.1016/j.jtcvs.2014.07.037. Epub 2014 Jul 31.

Results Reference

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PubMed Identifier

28711332

Citation

Subramaniam K, DeAndrade DS, Mandell DR, Althouse AD, Manmohan R, Esper SA, Varga JM, Badhwar V. Predictors of operating room extubation in adult cardiac surgery. J Thorac Cardiovasc Surg. 2017 Nov;154(5):1656-1665.e2. doi: 10.1016/j.jtcvs.2017.05.107. Epub 2017 Jun 13.

Results Reference

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PubMed Identifier

26448469

Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865. Erratum In: Anesthesiology. 2016 May;124(5):1201.

Results Reference

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PubMed Identifier

27496655

Citation

Murphy GS, Kopman AF. "To Reverse or Not To Reverse?": The Answer Is Clear! Anesthesiology. 2016 Oct;125(4):611-4. doi: 10.1097/ALN.0000000000001280. No abstract available.

Results Reference

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PubMed Identifier

20980910

Citation

Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.

Results Reference

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PubMed Identifier

27543551

Citation

Boon M, Martini C, Broens S, van Rijnsoever E, van der Zwan T, Aarts L, Dahan A. Improved postoperative oxygenation after antagonism of moderate neuromuscular block with sugammadex versus neostigmine after extubation in 'blinded' conditions. Br J Anaesth. 2016 Sep;117(3):410-1. doi: 10.1093/bja/aew246. No abstract available.

Results Reference

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PubMed Identifier

23665915

Citation

Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.

Results Reference

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PubMed Identifier

20935005

Citation

Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.

Results Reference

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PubMed Identifier

27484887

Citation

Park ES, Lim BG, Lee WJ, Lee IO. Sugammadex facilitates early recovery after surgery even in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: a single-center retrospective study. BMC Anesthesiol. 2016 Aug 2;16(1):48. doi: 10.1186/s12871-016-0221-2.

Results Reference

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PubMed Identifier

20688009

Citation

Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390.

Results Reference

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PubMed Identifier

20937718

Citation

Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex for reversal of neuromuscular block after rapid sequence intubation: a systematic review and economic assessment. Br J Anaesth. 2010 Nov;105(5):568-75. doi: 10.1093/bja/aeq270. Epub 2010 Oct 11.

Results Reference

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

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