Coca-Cola vs. Oxygen for Fatigue Management in Tibet Surgeons

Официальное название

Coca-Cola Versus Supplemental Oxygen on Fatigue Management in Tibet Surgeons

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Coca-Cola
  100 ml Coca-Cola every 30 minutes during the operation
• Другое Supplemental oxygen
  Continuous supply of oxygen (2 L/min) during the operation

Первичные конечные точки

• Attention decrease [Срок оценки: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)]

Вторичные конечные точки (1)

• Maximal voluntary contraction force decrease [Срок оценки: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Dorion D, Darveau S. Do micropauses prevent surgeon's fatigue and loss of accuracy associated with prolonged surgery? An experimental prospective study. Ann Surg. 2013 Feb;257(2):256-9. doi: 10.1097/SLA.0b013e31825efe87. PMID 22824853

Идентификаторы

NCT: NCT06557746 · ME-TBHP-24-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗