- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03621085
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
연구 개요
상세 설명
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.
With this background, we will test the hypothesis that ketamine 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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Texas
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Dallas, Texas, 미국, 75231
- Texas Health Presbyterian Hospital Dallas
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-45 years of age
- Healthy
- Non-obese (body mass index less than 30 kg/m2)
- Body mass greater than or equal to 65 kg
Exclusion Criteria:
- Subjects not in the defined age range
- Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy or breast feeding
- Body mass less than 65 kg
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Positive urine drug screen
- Currently taking pain modifying medication(s)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ketamine
Subjects will receive up to 20 mg Ketamine Hydrochloride while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
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A total of 20 mg of Ketamine Hydrochloride will be administered intravenously
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위약 비교기: Placebo
Subjects will receive placebo while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
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Subjects will receive placebo
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Stress Index
기간: 12 month
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Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and ketamine limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP).
This progressive lower-body negative pressure 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).
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12 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pressure Pain Tolerance
기간: 12 months
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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 after the subject has received placebo and ketamine.
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Craig G Crandall, Ph.D., University of Texas Southwestern Medical Center
간행물 및 유용한 링크
일반 간행물
- Watso JC, Huang M, Moralez G, Cramer MN, Hendrix JM, Cimino FA 3rd, Belval LN, Hinojosa-Laborde C, Crandall CG. Low dose ketamine reduces pain perception and blood pressure, but not muscle sympathetic nerve activity, responses during a cold pressor test. J Physiol. 2021 Jan;599(1):67-81. doi: 10.1113/JP280706. Epub 2020 Oct 20.
- Huang M, Watso JC, Moralez G, Cramer MN, Hendrix JM, Yoo JK, Badrov MB, Fu Q, Hinojosa-Laborde C, Crandall CG. Low-dose ketamine affects blood pressure, but not muscle sympathetic nerve activity, during progressive central hypovolemia without altering tolerance. J Physiol. 2020 Dec;598(24):5661-5672. doi: 10.1113/JP280491. Epub 2020 Oct 20.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STU 092017-068
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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