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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Fatigue

Treatments: Other: Coca-Cola; Other: Supplemental oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06557746

ME-TBHP-24-019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Cola group

Experimental group

Description:

100 ml cola every 30 minutes during the operation

Treatment:

Other: Coca-Cola

Oxygen group

Experimental group

Description:

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

Treatment:

Other: Supplemental oxygen