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

West Virginia University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Surgery

Treatments: Drug: Neostigmine; Drug: Glycopyrrolate; Drug: Rocuronium; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT03939923

1806161309

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Neostigmine/Glycopyrrolate

Active Comparator group

Description:

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).

Treatment:

Drug: Glycopyrrolate

Drug: Neostigmine

Drug: Rocuronium

Sugammadex

Active Comparator group

Description:

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).

Treatment:

Drug: Sugammadex

Drug: Rocuronium