NCT03939923

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery
• Coronary Artery Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2019-05-07
• Last updated: 2023-12-27
• Results posted: 2023-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study