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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06557746
Acronym
COMETS
Enrollment
22
Registered
2024-08-16
Start date
2024-09-01
Completion date
2025-04-01
Last updated
2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Surgeon Fatigue, Supplemental oxygen, Coca-Cola

Brief 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.

Interventions

100 ml Coca-Cola every 30 minutes during the operation

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

Sponsors

Tibet Autonomous Region People's Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

Intervention model description

Stepped-wedge cluster randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Attention decrease30 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

MeasureTime frameDescription
Maximal voluntary contraction force decrease30 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.

Contacts

Primary ContactDong Wu, M.D.
wudong@pumch.cn8618612671010
Backup ContactHaifeng Xu, M.D.
xuhf781120@sina.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026