Coca-Cola Versus Supplemental Oxygen on Fatigue Management in Tibet Surgeons
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Attention decrease
研究概览
简要总结
The study will be conducted among surgeons in Tibet, comparing the effects of Coca-Cola and supplemental oxygen on fatigue alleviation. Additionally, pre-planned subgroup analyses will examine the potential differences in effectiveness between Tibetan surgeons who have long lived in high-altitude areas and Han surgeons who work in these areas for shorter periods. The investigators hypothesize that for Tibetan surgeons, Coca-Cola will be more effective in alleviating fatigue, while for Han Chinese surgeons, supplemental oxygen will be more effective.
详细描述
Fatigue in surgeons can result in reduced concentration and muscle strength, compromising the safety of surgical procedures, particularly in high-altitude areas. In Tibet, surgeons often drink cola or inhale oxygen during operations, as these are believed to help alleviate fatigue. This study aims to evaluate the effects of Coca-Cola and supplemental oxygen in relieving fatigue among surgeons in Tibet and to investigate whether these effects vary based on the ethnicity of the doctors.
This study employs a stepped-wedge cluster randomized controlled trial design, recruiting 22 surgeons (k=22). Each doctor is scheduled to perform 24 surgeries and evaluated. At the beginning of the trial, all surgeons will drink cola. The supplemental oxygen will be administered in a random sequence to all participants until each has received the intervention. The primary outcome measure is the change in concentration performance scores before and after surgery (ΔCP). The secondary outcome measure is the change in maximum voluntary hand grip strength before and after surgery (ΔMVC). The study follows the intention-to-treat principle, including all subjects who have entered the randomization sequence in the analysis of the primary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention and the outcome measurement methods, it is difficult to blind both the participants and outcome assessors in this study. The investigators estimate that the impact of knowing the intervention group should be minimal, because the measurement of the outcomes in this study is relatively objective.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgeons employed at the People's Hospital of the Tibet Autonomous Region, including both Tibetan doctors with long-term experience in high-altitude areas and Han doctors working in high-altitude areas temporarily;
- •Capable of serving as the lead surgeon in operations lasting at least 2 hours;
- •Having lived and worked continuously in Lhasa for a minimum of 3 months, without traveling to low-altitude areas during this period;
- •Fully understanding of this research and willing to sign a written informed consent form.
排除标准
- 未提供
结局指标
主要结局
Attention decrease
时间窗: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Attention decrease is measured in terms of the difference in the concentration performance score (CP). The participants will take the d2 Test of Attention before and after every scheduled operation and get two CP scores (preoperative and postoperative). The higher the score, the better the attention. Therefore, a smaller difference (ΔCP) between preoperative and postoperative scores indicates a better effect in relieving fatigue.
次要结局
- Maximal voluntary contraction force decrease(30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours))
研究者
DONG WU
Professor of Gastroenterology
Tibet Autonomous Region People's Hospital