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The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food & Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.
The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | continuous infusion of 0.4 mcg/kg/hr |
|
| Placebo | Placebo Comparator | continuous infusion of 0.4 mcg/kg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Administered | total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours | up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Improves Analgesia | as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible' |
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Inclusion Criteria:
Exclusion Criteria:
Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 75 U/L)?
Yes or No?; Is Serum Creatinine < 1.5 mg/dl?
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| Name | Affiliation | Role |
|---|---|---|
| Alessia Pedoto, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | United States | |||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | continuous infusion of 0.4 mcg/kg/hr Dexmedetomidine |
| FG001 | Placebo | continuous infusion of 0.4 mcg/kg/hr Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 1, 2016 |
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|
| up to 24 hours |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively. | up to 24 hours |
| Memorial Sloan Kettering Cancer Center @ Suffolk |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center 1275 York Avenue | New York | New York | 10065 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | continuous infusion of 0.4 mcg/kg/hr Dexmedetomidine |
| BG001 | Placebo | continuous infusion of 0.4 mcg/kg/hr Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Total Opioid Administered | total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours | Posted | Median | Full Range | Morphine Milligram Equivalents | up to 4 hours |
|
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| |||||||||||||||||||||||||||||
| Secondary | Improves Analgesia | as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible' | Posted | Median | Full Range | score on a scale | up to 24 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively. | Posted | Count of Participants | Participants | up to 24 hours |
|
|
Up to 24 hours
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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 | Dexmedetomidine | continuous infusion of 0.4 mcg/kg/hr Dexmedetomidine | 33 | 148 | 5 | 148 | 0 | 148 |
| EG001 | Placebo | continuous infusion of 0.4 mcg/kg/hr Placebo | 37 | 152 | 8 | 152 | 0 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Intraoperative splenic injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Chylothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alessia Pedoto, MD | Memorial Sloan Kettering Cancer Center | 212-639-6840 | pedotoa@mskcc.org |
| Dec 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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