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This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.
This study will test the hypothesis that sufentanil will impair the capacity for a conscious human to tolerate a hemorrhagic insult.
The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil | Experimental | Sufentanil (30 microgram tablet) will be administered via a sublingual pill |
|
| Placebo | Placebo Comparator | Placebo will be administered via a sublingual pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil | Drug | Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance to Simulated Hemorrhage | Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and sufentanil limbs, by causing progressive central hypovolemia via lower-body negative pressure. This progressive lower-body negative pressure (LBNP) challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc). | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment | Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed when the subject has received placebo and sufentanil. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environmental Medicine | Dallas | Texas | 75231 | United States | ||
| University of Texas Southwestern Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Sufentanil | Participants received the placebo first followed by sufentanil. |
| FG001 | Sufentanil Then Placebo | Participants received the sufentanil first followed by placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Participants in Crossover Design | Participants received both placebo and sufentanil in a randomized crossover model. Thus, the reported baseline characteristics reflect those individuals who participated in both limbs. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Tolerance to Simulated Hemorrhage | Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and sufentanil limbs, by causing progressive central hypovolemia via lower-body negative pressure. This progressive lower-body negative pressure (LBNP) challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc). | Posted | Mean | Standard Deviation | min*mmHg | 6 hours |
|
Adverse data was collected over the 6 hours of the 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 | Sufentanil | Sufentanil (30 microgram tablet) will be administered via a sublingual pill Sufentanil: Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Crandall | University of Texas Southwestern Medical Center | 214-345-4623 | CraigCrandall@texashealth.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 | Aug 18, 2023 | Jun 17, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2023 | May 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed. |
|
| 6 hours |
| Dallas |
| Texas |
| 75390 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Body-Mass Index | Mean | Standard Deviation | kg/m^2 |
|
Sufentanil (30 microgram tablet) will be administered via a sublingual pill Sufentanil: Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed. |
| OG001 | Placebo | Placebo will be administered via a sublingual pill Placebo: Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed. |
|
|
| Secondary | Pain Assessment | Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed when the subject has received placebo and sufentanil. | Posted | Mean | Standard Deviation | kg | 6 hours |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | Placebo will be administered via a sublingual pill Placebo: Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed. | 0 | 29 | 0 | 29 | 0 | 29 |
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