Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
Condition: Surgery; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Rocuronium; Neostigmine; Glycopyrrolate; Sugammadex
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.; Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage); Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage); Reversal with Sugammadex (2mg/kg)
Intervention MeSH terms: Glycopyrrolate; Rocuronium; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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).
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass Grafting Surgery; Sugammadex

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).
    

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