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The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.
Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedetomidine is not approved for use longer than twenty-four hours and must only be administered in the Intensive Care Unit where patients can be continuously monitored.
This is a prospective, double-blinded, control group pilot study. One group (the control group) will receive a normal saline infusion and the second group (the treatment group) will receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open nursing unit (not an Intensive Care Unit).
During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical procedure after an optional loading dose. All patients will receive pain medication using a Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the incision under direction of the surgeon.
Before discharge from the PACU or ICU, each subject will receive either low-dose dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after the subject is discharged from either the PACU or the ICU to an open nursing unit. While on the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score will recorded every two hours until the treatment drug is stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug. |
|
| Dexmedetomidine | Active Comparator | The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine titrated over 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient. | An average of 24 hours, up to 30 hours per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the Amount of Respiratory Depression in Each Groups | Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ramsay, MD, MD | Baylor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center - Department of Anesthesiology | Dallas | Texas | 75246 | United States |
Participants were required to be between the ages of 18-85 and receiving general anesthesia with an AMerican Society of Anesthesiologists score of three or less, and undergoing thoracotomy surgery. Liver and renal failure patients were excluded.
Participants will be recruited from the from the BUMC Operating Room schedule prior to their procedure. Informed consent will be obtained in a secure area. Recruitment will continue until goal reached.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Blinded Normal saline infusion titrated as if study drug |
| FG001 | Dexmedetomidine | Received Dexmedetomidine for 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
13 were withdrawn from study prior to initiation of drug due to exclusion criteria that required an overnight stay in Recovery or ICU.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Standard of care |
| BG001 | Dexmedetomidine | titrated IV for 24 hours post ICU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient. | Participants completing the study were analyzed as per protocol | Posted | Number | 95% Confidence Interval | IV morphine equivalency in mg | An average of 24 hours, up to 30 hours per patient |
|
1 week from initiation of study drug.
0 serious adverse events were detected in patients enrolled in this study.
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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 | Normal Saline Group | Normal saline infused at calculated rate as if it were study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Pilot study with small numbers of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President Baylor Research Institute | Baylor Research Institute | 214-820-3296 | researchclinicaltrials@baylorhealth.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo (Normal Saline) | Other |
|
| Hours 6 to 16 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Measure the Amount of Respiratory Depression in Each Groups | Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours. | Posted | Mean | Standard Deviation | mmHg | Hours 6 to 16 |
|
|
|
|
| 0 |
| 19 |
| 10 |
| 19 |
| EG001 | Study Drug Group | Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU | 0 | 19 | 5 | 19 |
| Hypotension | Cardiac disorders | Systematic Assessment | systolic BP < 90 Mm Hg |
|
| Bradycardia | Cardiac disorders | Systematic Assessment | heart rate < 50 bpm |
|
| Tacycardia | Cardiac disorders | Systematic Assessment | Heart rate > 110 bpm |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |