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

Phase 4

Completed

• Conditions: Surgery; Coronary Artery Disease
• Interventions: Drug: Rocuronium; Drug: Neostigmine; Drug: Sugammadex; Drug: Glycopyrrolate

• Registration Number: NCT03939923
• Lead Sponsor: West Virginia University

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-02
• Study Start: 2019-05-01
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Results First Submitted: 2023-04-30
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-20
• Results First Posted: 2023-12-22
• Last Update Submitted: 2023-12-23
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine/Glycopyrrolate	Neostigmine	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).
Neostigmine/Glycopyrrolate	Rocuronium	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).
Neostigmine/Glycopyrrolate	Glycopyrrolate	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).
Sugammadex	Rocuronium	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).
Sugammadex	Sugammadex	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).

Primary Outcome Measures

Name	Time	Method
Time to Extubation	0 minutes of study drug to 3 days after study drug administration	Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation".

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)	0 minutes to 2 hours after study drug administration	Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea
Tidal Volume	between 30 minutes to 1 hour after extubation	Tidal volume post-reversal prior to extubation
Peak Flow Rate	30-60 minutes post-extubation	Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
Heart Rate	0 minutes to 2 hours after study drug administration	Heart rate post-reversal prior to extubation
Swallowing Capacity	Between 30 and 60 minutes post-extubation	In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking.

Trial Locations

Locations (1)

WVU Medicine; 🇺🇸 Morgantown, West Virginia, United States