Phase 4 N=84 Randomized Single-blind Treatment

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

Surgery · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT03939923 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Dec 2023

Primary outcome: Primary: Time to Extubation — 10.4; 6 Minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rocuronium (Drug); Neostigmine (Drug); Glycopyrrolate (Drug); Sugammadex (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Virginia University
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Extubation	10.4; 6	—
SECONDARY Heart Rate	81.5385; 81.1622	—
SECONDARY Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)	105.6; 112.1	—
SECONDARY Tidal Volume	1.16; 1.0975	—
SECONDARY Peak Flow Rate	1.4609; 1.416	—
SECONDARY Swallowing Capacity	29; 33; 4; 2; 3; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03939923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.