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NCT Number: NCT06557746

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

Coca-Cola

Other

100 ml Coca-Cola every 30 minutes during the operation

Supplemental Oxygen

Other

Continuous supply of oxygen (2 L/min) during the operation

Primary outcomes

  1. Attention decrease

    Time frame: 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.

Secondary outcomes

  1. Maximal voluntary contraction force decrease

    Time frame: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)

    Maximal voluntary contraction force (MVC) is measured by hand dynamometer. The participants will be tested before and after every scheduled operation and get two MVC (preoperative and postoperative). The greater the strength, the less fatigued the hand muscles are. Therefore, a smaller difference (ΔMVC) between preoperative and postoperative scores indicates a better effect in relieving fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu, M.D.

CONTACT

[email protected]

8618612671010

Haifeng Xu, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Tibet Autonomous Region People's Hospital

Registry information

Official study title

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

Acronym: COMETS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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