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出境医 / 临床实验 / Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery

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

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
Layout table for study information
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
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)
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Matthew Ellison, MD 304-598-4929 mellison@wvumedicine.org
Contact: Connie Tennant, RN, CCRP 304-598-6193 cstennant@wvumedicine.org

Locations
Layout table for location information
United States, West Virginia
WVU Medicine Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Matthew Ellison, MD    304-598-4929    mellison@wvumedicine.org   
Contact: Connie Tennant, RN, CCRP    304-598-6193    cstennant@wvumedicine.org   
Principal Investigator: Matthew Ellison, MD         
Sub-Investigator: Pavithra Ranganathan, MD         
Sub-Investigator: Brian Grose, MD         
Sub-Investigator: Heather Hayanga, MD         
Sub-Investigator: Jeff Puette, MD         
Sub-Investigator: Hong Wang, MD         
Sub-Investigator: Daniel Sloyer, MD         
Sub-Investigator: Chris Cook, MD         
Sub-Investigator: Vinay Badhwar, MD         
Sub-Investigator: Muhammad Salman, MD         
Sub-Investigator: Harold Roberts, MD         
Sub-Investigator: Lawrence Wei, MD         
Sponsors and Collaborators
West Virginia University
Tracking Information
First Submitted Date  ICMJE February 2, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019) 		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".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03939923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Heart rate [ Time Frame: at 0 mintues to 2 hours after study drug administration ]
    Heart rate post-reversal prior to extubation
  • 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
  • Tidal Volume [ Time Frame: between 30 minutes to 1 hour after extubation ]
    Tidal volume post-reversal prior to extubation
  • Peak Flow Rate [ Time Frame: 30-60 minutes post-extubation ]
    Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
  • Swallowing Capacity [ Time Frame: 30-60 minutes post-extubation ]
    Swallowing capacity measured by Functional Dysphagia screen administered at 30 - 60 mins post extubation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 3, 2019)
  • Oxygen Saturation [ Time Frame: 2 hours post-extubation every 15 minutes ]
    Oxygen saturation post-extubation for subsequent 2 hours documented every 15 minutes
  • Post-extubation Oxygen Requirements [ Time Frame: 2 hours post-extubation ]
    Post-extubation Oxygen requirements in subsequent 2 hours
  • 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
  • Reintubation Incidence [ Time Frame: 24 hours post-extubation ]
    Reintubation incidence in the first 24 hours post-extubation
  • Occurrence of Postoperative Respiratory Complications [ Time Frame: 0 hours after study drug to 24 hours after study drug ]
    Postoperative respiratory complication
  • Occurrence of Postoperative Cardiac Complications [ Time Frame: from 0 hours after study drug to 2 hours after study drug ]
    Postoperative cardiac complications.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
Official Title  ICMJE Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Surgery
  • Coronary Artery Disease
Intervention  ICMJE
  • 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)
  • Drug: Sugammadex
    Reversal with Sugammadex (2mg/kg)
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Rocuronium
    • Drug: Neostigmine
    • Drug: Glycopyrrolate
  • 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).
    Interventions:
    • Drug: Rocuronium
    • Drug: Sugammadex
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pongrácz A, Szatmári S, Nemes R, Fülesdi 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.
  • 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. Review.
  • 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.
  • 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. Review.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019) 		84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Ellison, MD 304-598-4929 mellison@wvumedicine.org
Contact: Connie Tennant, RN, CCRP 304-598-6193 cstennant@wvumedicine.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939923
Other Study ID Numbers  ICMJE WVU Protocol #: 1806161309
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Ellison, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account West Virginia University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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