Trial Outcomes & Findings for Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery (NCT NCT03939923)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

84 participants

Primary outcome timeframe

0 minutes of study drug to 3 days after study drug administration

Results posted on

2023-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	42	42
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)	Total n=71 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 8.36 • n=36 Participants	62.1 years STANDARD_DEVIATION 8.77 • n=35 Participants	61.8 years STANDARD_DEVIATION 8.56 • n=71 Participants
Sex: Female, Male Female	11 Participants n=36 Participants	10 Participants n=35 Participants	21 Participants n=71 Participants
Sex: Female, Male Male	25 Participants n=36 Participants	25 Participants n=35 Participants	50 Participants n=71 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Time to Extubation	10.4 Minutes Standard Deviation 5.9	6 Minutes Standard Deviation 4.7

SECONDARY outcome

Timeframe: 0 minutes to 2 hours after study drug administration

Heart rate post-reversal prior to extubation

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Heart Rate	81.5385 beats per minute Standard Deviation 13.6302	81.1622 beats per minute Standard Deviation 10.9735

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)	105.6 mmHg Standard Deviation 18.2067	112.1 mmHg Standard Deviation 14.939

SECONDARY outcome

Timeframe: between 30 minutes to 1 hour after extubation

Tidal volume post-reversal prior to extubation

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Tidal Volume	1.16 Liters Standard Deviation 0.5957	1.0975 Liters Standard Deviation 0.4977

SECONDARY outcome

Timeframe: 30-60 minutes post-extubation

Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Peak Flow Rate	1.4609 L/min Standard Deviation 0.9968	1.416 L/min Standard Deviation 0.8466

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Neostigmine/Glycopyrrolate n=36 Participants 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)	Sugammadex n=35 Participants 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)
Swallowing Capacity Not assessed	3 Participants	0 Participants
Swallowing Capacity Passed	29 Participants	33 Participants
Swallowing Capacity No Pass	4 Participants	2 Participants

Adverse Events

Neostigmine/Glycopyrrolate

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Sugammadex

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neostigmine/Glycopyrrolate n=36 participants at risk 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)	Sugammadex n=35 participants at risk 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)
Cardiac disorders Myocardial Infarction	2.8% 1/36 • Number of events 1 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.	0.00% 0/35 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.
Vascular disorders R ICA Stroke	2.8% 1/36 • Number of events 1 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.	0.00% 0/35 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.
Vascular disorders R MCA Stroke	0.00% 0/36 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.	2.9% 1/35 • Number of events 1 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.

Other adverse events

Other adverse events
Measure	Neostigmine/Glycopyrrolate n=36 participants at risk 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)	Sugammadex n=35 participants at risk 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)
Cardiac disorders Atrial Fibrillation	0.00% 0/36 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.	2.9% 1/35 • Number of events 1 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.
Cardiac disorders Incomplete Right Bundle Branch Block	2.8% 1/36 • Number of events 1 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.	0.00% 0/35 • Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record. Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.

Additional Information

Director of Research in Department of Anesthesiology

West Virginia University

Phone: 304-598-4122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place