Trial Outcomes & Findings for Prospective, Double Blind, Placebo Control, Bariatric IV Ace (NCT NCT02452320)

Last Updated: 2018-04-20

Results Overview

Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Possible scores range from 0-150, and scores with a higher value indicate a better outcome. Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

136 participants

Primary outcome timeframe

Patients will be followed for the duration of hospital stay, expected average of 3 days.

Results posted on

2018-04-20

Participant Flow

136 subjects were informed of and consented to participate. Due to unforeseen scheduling conflicts and canceled surgeries, we recruited more subjects in order to reach our 128 recruitment mark for statistical analysis. 1 subject was not included in the analysis due to a prolonged hospitalization not related to the study.

Participant milestones

Participant milestones
Measure	Placebo Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Overall Study STARTED	64	64
Overall Study COMPLETED	64	63
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Overall Study Adverse Event	0	1

Baseline Characteristics

When added the breakdown of participants is equivalent to the overall number of participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=64 Participants Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV n=63 Participants Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Total n=127 Participants Total of all reporting groups
Age, Continuous	39.1 years STANDARD_DEVIATION 12.2 • n=64 Participants	42.2 years STANDARD_DEVIATION 12.2 • n=63 Participants	40.7 years STANDARD_DEVIATION 12.2 • n=127 Participants
Sex: Female, Male Female	47 Participants n=64 Participants	45 Participants n=63 Participants	92 Participants n=127 Participants
Sex: Female, Male Male	17 Participants n=64 Participants	18 Participants n=63 Participants	35 Participants n=127 Participants
Race/Ethnicity, Customized White	24 Participants n=24 Participants • When added the breakdown of participants is equivalent to the overall number of participants	21 Participants n=21 Participants • When added the breakdown of participants is equivalent to the overall number of participants	45 Participants n=45 Participants • When added the breakdown of participants is equivalent to the overall number of participants
Race/Ethnicity, Customized Black or African American	20 Participants n=64 Participants • When added the breakdown of participants is equivalent to the overall number of participants	16 Participants n=63 Participants • When added the breakdown of participants is equivalent to the overall number of participants	36 Participants n=127 Participants • When added the breakdown of participants is equivalent to the overall number of participants
Race/Ethnicity, Customized More than one race	7 Participants n=64 Participants • When added the breakdown of participants is equivalent to the overall number of participants	13 Participants n=63 Participants • When added the breakdown of participants is equivalent to the overall number of participants	20 Participants n=127 Participants • When added the breakdown of participants is equivalent to the overall number of participants
Race/Ethnicity, Customized Unknown or Not Reported	13 Participants n=64 Participants • When added the breakdown of participants is equivalent to the overall number of participants	13 Participants n=63 Participants • When added the breakdown of participants is equivalent to the overall number of participants	26 Participants n=127 Participants • When added the breakdown of participants is equivalent to the overall number of participants
Region of Enrollment United States	64 participants n=64 Participants	63 participants n=63 Participants	127 participants n=127 Participants
Height (cm)	164.8 cm STANDARD_DEVIATION 10.8 • n=64 Participants	165.5 cm STANDARD_DEVIATION 9.2 • n=63 Participants	165.2 cm STANDARD_DEVIATION 10 • n=127 Participants
Weight (kg)	130 kg STANDARD_DEVIATION 27.1 • n=64 Participants	127.5 kg STANDARD_DEVIATION 25.4 • n=63 Participants	128.8 kg STANDARD_DEVIATION 26.3 • n=127 Participants
BMI	47.3 kg/m^2 STANDARD_DEVIATION 7.9 • n=64 Participants	46.6 kg/m^2 STANDARD_DEVIATION 7.7 • n=63 Participants	46.9 kg/m^2 STANDARD_DEVIATION 7.8 • n=127 Participants

PRIMARY outcome

Timeframe: Patients will be followed for the duration of hospital stay, expected average of 3 days.

Population: Subjects were administered a QoR-15 Survey pre-operatively as a baseline, and on post-operative days 1 and 2. Some subjects were discharged prior to the administration of the QoR-15 on post-operative day 2 and therefore there is no data for those subjects that we no longer in the hospital.

Outcome measures

Outcome measures
Measure	Placebo n=64 Participants Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV n=63 Participants Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Quality of Recovery-15 Patient Survey POD 2	118.3 units on a scale Standard Deviation 17.3	117.1 units on a scale Standard Deviation 21.1
Quality of Recovery-15 Patient Survey POD 1	107.2 units on a scale Standard Deviation 18.8	108.6 units on a scale Standard Deviation 20.9

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, expected average of 3 days.

Population: Subjects LoS were recorded from time of PACU admission till time that Discharge Orders were completed.

Monitoring the length of hospital stay after undergoing surgery

Outcome measures

Outcome measures
Measure	Placebo n=64 Participants Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV n=63 Participants Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Length of Hospital Stay	1.96 days Interval 1.8 to 2.31	1.87 days Interval 1.66 to 2.06

SECONDARY outcome

Timeframe: Costs incurred during hospital stay, expected average of 3 days.

Population: Used the Hospital cost data for the subjects enrolled in both arms of the study for the duration of their hospitalization.

Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.

Outcome measures

Outcome measures
Measure	Placebo n=64 Participants Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV n=63 Participants Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Hospital Costs	12,977 Dollars (USD)	12,885 Dollars (USD)

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen IV

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=64 participants at risk Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm. Placebo: Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia	Acetaminophen IV n=63 participants at risk Subjects randomized into the active treatment group will receive intravenous acetaminophen intravenous acetaminophen: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/64 • Adverse event data was collected during the time in which the subject was in the hospital. Our consent form allowed access to their electronic medical record while the subject was in the hospital. Adverse events were monitored while the subject was hospitalized, an average of 2-3 days. Once discharged from this hospitalization, the subjects were no longer followed.	1.6% 1/63 • Adverse event data was collected during the time in which the subject was in the hospital. Our consent form allowed access to their electronic medical record while the subject was in the hospital. Adverse events were monitored while the subject was hospitalized, an average of 2-3 days. Once discharged from this hospitalization, the subjects were no longer followed.

Other adverse events

Adverse event data not reported

Additional Information

Farrell Cooke, Senior Research Assistant

Weill Cornell Medicine

Phone: 212-746-2774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place