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Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen.
Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery.
The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation.
After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor.
48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery.
At discharge, the patient will be given two questionnaires about pain and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous 0.9% sodium chloride | Placebo Comparator | 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. |
|
| Intravenous Acetaminophen | Experimental | Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Acetaminophen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hypoxemia | Hypoxemia is measured as minutes with hypoxemia (Spo2 <90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively. | the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Pain Score During Initial 48 Postoperative Hours | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. Pain was recorded at roughly 15-minute intervals in the postanesthesia care unit and at 4-hour intervals on surgical wards |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32721009 | Derived | Turan A, Essber H, Saasouh W, Hovsepyan K, Makarova N, Ayad S, Cohen B, Ruetzler K, Soliman LM, Maheshwari K, Yang D, Mascha EJ, Ali Sakr Esa W, Kessler H, Delaney CP, Sessler DI; FACTOR Study Group. Effect of Intravenous Acetaminophen on Postoperative Hypoxemia After Abdominal Surgery: The FACTOR Randomized Clinical Trial. JAMA. 2020 Jul 28;324(4):350-358. doi: 10.1001/jama.2020.10009. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous 0.9% Sodium Chloride | 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
| FG001 | Intravenous Acetaminophen | Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous 0.9% Sodium Chloride | 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
| BG001 | Intravenous Acetaminophen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Hypoxemia | Hypoxemia is measured as minutes with hypoxemia (Spo2 <90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively. | Patients were analyzed according to their randomized group, excluding patients who did not receive study intervention. 28 patients (5%) did not have any data recorded due to unexpected technical issues. | Posted | Median | Inter-Quartile Range | min/h | the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter. |
|
90 days
No adverse events were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Acetaminophen | Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alparslan Turan, MD | Cleveland Clinic | 216-445-0998 | turana@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2015 | Dec 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Time Weighted Pain Score in Post Anesthesia Care Unit | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time-weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Fatigue Score on Morning of Postoperative Day 1 | Fatigue scores were calculated on a scale of 1 to 10, with 1 being no fatigue and 10 being the worst fatigue imaginable. | Postoperative day 1 |
| Lowest RASS Score During Initial 48 Postoperative Hours | Sedation was estimated by the RASS score and recorded at 2-hour intervals by ward nurses per clinical routine during the initial 48 postoperative hours. The Richmond Agitation-Sedation Scale (RASS) is scored from -5 to +4, with -5 being unarousable, 0 being alert and calm, and +4 being combative. | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Time Spent in Sitting or Upright Position | Treatment effect data are reported as ratios of geometric means | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Opioid Consumption - Intravenous Morphine Equivalents | Total opioid consumption over the initial 48 postoperative hours was extracted from patients' medical records and converted to intravenous morphine equivalents | Initial 48 postoperative hours |
| Incidence of Postoperative Nausea and Vomiting | Patients were asked about postoperative nausea and vomiting in the postanesthesia care unit, at 4-hour intervals while awake through the remaining initial day of surgery, and on the first and second postoperative mornings. | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Incidence of Low Respiratory Function Event | A low respiratory function event was defined as an episode of less than 40% of predicted minute ventilation for 2 minutes. | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
| Total Anesthetic Dose From Induction to Extubation | Total anesthetic dose is measured in minimal alveolar concentration hours. | Induction to extubation (3 hours on average) |
Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Intravenous 0.9% Sodium Chloride | 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen |
|
|
|
| Secondary | Time-weighted Pain Score During Initial 48 Postoperative Hours | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. Pain was recorded at roughly 15-minute intervals in the postanesthesia care unit and at 4-hour intervals on surgical wards | Data on the outcome could not be collected for 7 patients in the IV acetaminophen group and 5 patients in the IV sodium chloride group. | Posted | Mean | Standard Deviation | score on a scale | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Time Weighted Pain Score in Post Anesthesia Care Unit | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time-weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. | Data on the outcome could not be collected for 2 patients in the IV acetaminophen group and 6 patients in the IV sodium chloride group. | Posted | Mean | Standard Deviation | score on a scale | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Fatigue Score on Morning of Postoperative Day 1 | Fatigue scores were calculated on a scale of 1 to 10, with 1 being no fatigue and 10 being the worst fatigue imaginable. | Data on the outcome could not be collected for 12 patients in the IV acetaminophen group and 15 patients in the IV sodium chloride group. | Posted | Mean | Standard Deviation | score on a scale | Postoperative day 1 |
|
|
|
|
| Secondary | Lowest RASS Score During Initial 48 Postoperative Hours | Sedation was estimated by the RASS score and recorded at 2-hour intervals by ward nurses per clinical routine during the initial 48 postoperative hours. The Richmond Agitation-Sedation Scale (RASS) is scored from -5 to +4, with -5 being unarousable, 0 being alert and calm, and +4 being combative. | Data on the outcome could not be collected for 91 patients in the IV acetaminophen group and 86 patients in the IV sodium chloride group. | Posted | Mean | Standard Deviation | score on a scale | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Time Spent in Sitting or Upright Position | Treatment effect data are reported as ratios of geometric means | Data on the outcome could not be collected for 31 patients in the IV acetaminophen group and 37 patients in the IV sodium chloride group. | Posted | Median | Inter-Quartile Range | hours | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Opioid Consumption - Intravenous Morphine Equivalents | Total opioid consumption over the initial 48 postoperative hours was extracted from patients' medical records and converted to intravenous morphine equivalents | Data on the outcome could not be collected for 3 patients in the IV acetaminophen group and 7 patients in the IV sodium chloride group. | Posted | Median | Inter-Quartile Range | mg | Initial 48 postoperative hours |
|
|
|
|
| Secondary | Incidence of Postoperative Nausea and Vomiting | Patients were asked about postoperative nausea and vomiting in the postanesthesia care unit, at 4-hour intervals while awake through the remaining initial day of surgery, and on the first and second postoperative mornings. | Data on the outcome could not be collected for 3 patients in the IV acetaminophen group and 7 patients in the IV sodium chloride group. | Posted | Count of Participants | Participants | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Incidence of Low Respiratory Function Event | A low respiratory function event was defined as an episode of less than 40% of predicted minute ventilation for 2 minutes. | Data on the outcome could not be collected for 95 patients in the IV acetaminophen group and 124 patients in the IV sodium chloride group. | Posted | Count of Participants | Participants | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) |
|
|
|
|
| Secondary | Total Anesthetic Dose From Induction to Extubation | Total anesthetic dose is measured in minimal alveolar concentration hours. | Data on the outcome could not be collected for 1 patient in the IV acetaminophen group. | Posted | Median | Inter-Quartile Range | minimal alveolar concentration hours | Induction to extubation (3 hours on average) |
|
|
|
|
| 0 |
| 283 |
| 0 |
| 283 |
| 0 |
| 283 |
| EG001 | Intravenous 0.9% Sodium Chloride | 0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge. Intravenous Acetaminophen | 0 | 287 | 0 | 287 | 0 | 287 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |