Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Acute Mountain Sickness
研究概览
简要总结
This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).
详细描述
This study will be a double-blind randomized controlled trial to investigate the utility of prochlorperazine maleate versus placebo for the chemoprophylaxis of acute mountain sickness on rapid ascent to 4,348 meters, specifically the summit of Mount Blue Sky in the Mount Blue Sky Wilderness. Participants will be evaluated for AMS utilizing the 2018 LLQ both the evening of and morning after ascent. The primary outcome will be the presence of AMS, defined by a 2018 LLQ score equal to or greater than 3, including the presence of a headache at any measured point during the study. Individuals will convene the morning of the study in Golden, Colorado where they will receive breakfast and either placebo or prochlorperazine. They will then be driven to Summit Lake where they will break for lunch and receive the second dose of placebo or prochlorperazine. They will then hike to the Mount Blue Sky summit where they will receive their third and final dose of either placebo or intervention, spend the night in the structures at the summit, and be assessed for AMS via LLQ. In the morning, they will be assessed for AMS again, receive breakfast, and then be driven back to the original meeting point. They will be monitored by Emergency Physicians at all points during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be a placebo-controlled, double blinded trial. Intervention and placebo are non-identical though very similar in appearance and will be stored in opaque vials. A non-blinded study team member will be solely in charge of dispensing medications.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18 years old.
排除标准
- •Individuals <18 years old or >75 years old
- •Pregnant women
- •Individuals who reside at or have slept at elevations >1,800 meters in the last two weeks
- •Individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation
- •Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia
- •Individuals with known allergies to prochlorperazine or phenothiazines
- •Individuals taking medications with significant medication interactions with prochlorperazine: Dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, Yohimbe.
- •Individuals with a history of dementia
- •Individuals who lack decision making capacity
研究组 & 干预措施
Prochlorperazine Maleate
This arm will be the interventional/experimental arm receiving prochlorperazine maleate, further described in experimental arm section.
干预措施: Prochlorperazine Maleate (Drug)
Placebo
The placebo arm individuals will receive a non-identical placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Mountain Sickness
时间窗: The primary outcome will be assessed during the discreet roughly 36 hour trial period. LLQs will be administered the evening of and morning after arrival to peak altitude, or at any point of self reported altitude illness.
The primary outcome will be the presence of AMS, defined by a 2018 Lake Louise Questionnaire (LLQ) score of equal to or greater than 3, including the presence of a headache at any measured point during the study.
次要结局
未报告次要终点