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Not Yet RecruitingNCT06557746

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
22 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERCoca-Cola100 ml Coca-Cola every 30 minutes during the operation
OTHERSupplemental oxygenContinuous supply of oxygen (2 L/min) during the operation

Timeline

Start date
2024-09-01
Primary completion
2025-03-01
Completion
2025-04-01
First posted
2024-08-16
Last updated
2024-08-16

Source: ClinicalTrials.gov record NCT06557746. Inclusion in this directory is not an endorsement.