Clinical trial NCT03939923: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Coronary Artery Disease
Keywords: Coronary Artery Bypass Grafting Surgery
Sugammadex
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Extubation
timeFrame: 0 minutes of study drug to 3 days after study drug administration
Secondary outcomes:
measure: Heart Rate
timeFrame: 0 minutes to 2 hours after study drug administration
measure: Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
timeFrame: 0 minutes to 2 hours after study drug administration
measure: Tidal Volume
timeFrame: between 30 minutes to 1 hour after extubation
measure: Peak Flow Rate
timeFrame: 30-60 minutes post-extubation
measure: Swallowing Capacity
timeFrame: Between 30 and 60 minutes post-extubation
Other outcomes:
measure: Oxygen Saturation
timeFrame: 30 minutes post-extubation
measure: Post-extubation Oxygen Requirements
timeFrame: 2 hours post-extubation
measure: Length of Stay Cardiac Intensive Care Unit
timeFrame: 0 days after study drug to 100 days after study drug
measure: Reintubation Incidence
timeFrame: 24 hours post-extubation
measure: Occurrence of Postoperative Respiratory Complications
timeFrame: 0 hours after study drug to 24 hours after study drug
measure: Occurrence of Postoperative Cardiac Complications
timeFrame: from 0 hours after study drug to 2 hours after study drug
Locations:
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.