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

NCT03939923 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1806161309
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgery; Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafting Surgery; Sugammadex

Outcome Measures

Primary Outcomes (1)

• 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".

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

Secondary Outcomes (5)

• Heart Rate

  0 minutes to 2 hours after study drug administration

• Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)

  0 minutes to 2 hours after study drug administration

• Tidal Volume

  between 30 minutes to 1 hour after extubation

• Peak Flow Rate

  30-60 minutes post-extubation

• Swallowing Capacity

  Between 30 and 60 minutes post-extubation

Other Outcomes (6)

• Oxygen Saturation

  30 minutes post-extubation

• Post-extubation Oxygen Requirements

  2 hours post-extubation

• Length of Stay Cardiac Intensive Care Unit

  0 days after study drug to 100 days after study drug

Study Arms (2)

Neostigmine/Glycopyrrolate

ACTIVE COMPARATOR

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 train of four (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; Drug: Neostigmine; Drug: Glycopyrrolate

Sugammadex

ACTIVE COMPARATOR

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 train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).

Drug: Rocuronium; Drug: Sugammadex

Interventions

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/Glycopyrrolate; Sugammadex

Neostigmine DRUG

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

Neostigmine/Glycopyrrolate

Glycopyrrolate DRUG

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

Neostigmine/Glycopyrrolate

Sugammadex DRUG

Reversal with Sugammadex (2mg/kg)

Sugammadex

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine

Morgantown, West Virginia, 26506, United States

Location

Related Publications (12)

• 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.

  PMID: 25173117 BACKGROUND

• 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.

  PMID: 28711332 BACKGROUND

• 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.

  PMID: 26448469 BACKGROUND

• 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.

  PMID: 27496655 BACKGROUND

• 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.

  PMID: 20980910 BACKGROUND

• 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.

  PMID: 27543551 BACKGROUND

• 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.

  PMID: 23665915 BACKGROUND

• 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.

  PMID: 20935005 BACKGROUND

• 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.

  PMID: 27484887 BACKGROUND

• 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.

  PMID: 20688009 BACKGROUND

• 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.

  PMID: 20937718 BACKGROUND

• Ellison MB, Statler A, Grose B, Sloyer D, Hayanga H, Ellison PR, Funke C. Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial. BMC Anesthesiol. 2025 Dec 23;25(1):612. doi: 10.1186/s12871-025-03456-6.

  PMID: 41437213 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rocuronium; Neostigmine; Glycopyrrolate; Sugammadex

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Director of Research in Department of Anesthesiology
• Organization: West Virginia University

david.scalzo@hsc.wvu.edu

304-598-4122

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Cardiovascular Anesthesiology, Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: December 27, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)