Conditions: Surgery Coronary Artery Disease
Keywords: Coronary Artery Bypass Grafting Surgery Sugammadex
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

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.

Arms:
arm 1: 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). arm 2: 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).

Interventions: intervention 1: Rocuronium intervention 2: Neostigmine intervention 3: Glycopyrrolate intervention 4: Sugammadex
Intervention descriptions: intervention 1: 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 2: Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) intervention 3: Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) intervention 4: Reversal with Sugammadex (2mg/kg)

Protocol document:
Prot_SAP_ICF_000.pdf: 
Official title: Role of Sugammadex as Reversal Agent in Patients 
Extubated Immediately After Isolated Coronary Artery Bypass Grafting 
Surgery 
NCT number: NCT03939923 
Document date: 09/25/2020 
Informed consent and Protocol Summary