Clinical trial NCT06557746: Coca-Cola vs. Oxygen for Fatigue Management in Tibet Surgeons
Official title: Coca-Cola Versus Supplemental Oxygen on Fatigue Management in Tibet Surgeons
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Keywords: Surgeon Fatigue
Supplemental oxygen
Coca-Cola
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Tibet Autonomous Region People's Hospital
First posted: 2024-08-16
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Attention decrease
timeFrame: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Secondary outcomes:
measure: Maximal voluntary contraction force decrease
timeFrame: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Tibet Autonomous Region People's Hospital
name: Dong Wu, M.D.
role: STUDY_CHAIR
affiliation: Tibet Autonomous Region People's Hospital
name: Haifeng Xu, M.D.
role: STUDY_CHAIR
References:
citation: 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.