Coronary Artery Disease, Surgery
Conditions
Keywords
Coronary Artery Bypass Grafting Surgery, Sugammadex
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.
Interventions
DRUGRocuronium
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.
DRUGNeostigmine
Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
DRUGGlycopyrrolate
Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
DRUGSugammadex
Reversal with Sugammadex (2mg/kg)
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Intervention model description
Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage). Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 0 minutes to 2 hours after study drug administration | Heart rate post-reversal prior to extubation |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation | 30 minutes post-extubation | Oxygen saturation post-extubation |
| Post-extubation Oxygen Requirements | 2 hours post-extubation | Post-extubation Oxygen requirements in subsequent 2 hours |
| Length of Stay Cardiac Intensive Care Unit | 0 days after study drug to 100 days after study drug | Length of stay in the cardiac intensive care from onset of reversal drugs |
| Reintubation Incidence | 24 hours post-extubation | Reintubation incidence in the first 24 hours post-extubation |
| Occurrence of Postoperative Respiratory Complications | 0 hours after study drug to 24 hours after study drug | Postoperative respiratory complication including re-intubation |
| Occurrence of Postoperative Cardiac Complications | from 0 hours after study drug to 2 hours after study drug | Postoperative cardiac complications including myocardial infarction, arrythmias |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neostigmine/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 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).
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.
Neostigmine: Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
Glycopyrrolate: Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) | 36 |
| 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 TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).
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.
Sugammadex: Reversal with Sugammadex (2mg/kg) | 35 |
| Total | 71 |
Baseline characteristics
| Characteristic | Neostigmine/Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 8.36 | 62.1 years STANDARD_DEVIATION 8.77 | 61.8 years STANDARD_DEVIATION 8.56 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 1 / 36 | 1 / 35 |
| serious Total, serious adverse events | 2 / 36 | 1 / 35 |
Outcome results
Primary
Time to Extubation
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.
Time frame: 0 minutes of study drug to 3 days after study drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Time to Extubation | 10.4 Minutes | Standard Deviation 5.9 |
| Sugammadex | Time to Extubation | 6 Minutes | Standard Deviation 4.7 |
Secondary
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea
Time frame: 0 minutes to 2 hours after study drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal) | 105.6 mmHg | Standard Deviation 18.2067 |
| Sugammadex | Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal) | 112.1 mmHg | Standard Deviation 14.939 |
Secondary
Heart Rate
Heart rate post-reversal prior to extubation
Time frame: 0 minutes to 2 hours after study drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Heart Rate | 81.5385 beats per minute | Standard Deviation 13.6302 |
| Sugammadex | Heart Rate | 81.1622 beats per minute | Standard Deviation 10.9735 |
Secondary
Peak Flow Rate
Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
Time frame: 30-60 minutes post-extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Peak Flow Rate | 1.4609 L/min | Standard Deviation 0.9968 |
| Sugammadex | Peak Flow Rate | 1.416 L/min | Standard Deviation 0.8466 |
Secondary
Swallowing Capacity
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.
Time frame: Between 30 and 60 minutes post-extubation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Swallowing Capacity | Passed | 29 Participants |
| Neostigmine/Glycopyrrolate | Swallowing Capacity | No Pass | 4 Participants |
| Neostigmine/Glycopyrrolate | Swallowing Capacity | Not assessed | 3 Participants |
| Sugammadex | Swallowing Capacity | Passed | 33 Participants |
| Sugammadex | Swallowing Capacity | No Pass | 2 Participants |
| Sugammadex | Swallowing Capacity | Not assessed | 0 Participants |
Secondary
Tidal Volume
Tidal volume post-reversal prior to extubation
Time frame: between 30 minutes to 1 hour after extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Tidal Volume | 1.16 Liters | Standard Deviation 0.5957 |
| Sugammadex | Tidal Volume | 1.0975 Liters | Standard Deviation 0.4977 |
Other Pre-specified
Length of Stay Cardiac Intensive Care Unit
Length of stay in the cardiac intensive care from onset of reversal drugs
Time frame: 0 days after study drug to 100 days after study drug
Other Pre-specified
Occurrence of Postoperative Cardiac Complications
Postoperative cardiac complications including myocardial infarction, arrythmias
Time frame: from 0 hours after study drug to 2 hours after study drug
Other Pre-specified
Occurrence of Postoperative Respiratory Complications
Postoperative respiratory complication including re-intubation
Time frame: 0 hours after study drug to 24 hours after study drug
Other Pre-specified
Oxygen Saturation
Oxygen saturation post-extubation
Time frame: 30 minutes post-extubation
Other Pre-specified
Post-extubation Oxygen Requirements
Post-extubation Oxygen requirements in subsequent 2 hours
Time frame: 2 hours post-extubation
Other Pre-specified
Reintubation Incidence
Reintubation incidence in the first 24 hours post-extubation
Time frame: 24 hours post-extubation