Phase 4
Completed N=84
Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
Surgery · Coronary Artery Disease
Source: ClinicalTrials.gov NCT03939923 ↗
Enrolled (actual)
84
Serious AEs
4.2%
Results posted
Dec 2023
Primary outcomePrimary: Time to Extubation — 10.4; 6 Minutes
◆ Published Evidence
Not yet cited
0citations
Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial.
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).
Linked Publications
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Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03939923) and the linked publication. 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. Informational only — not medical advice.