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

Not Applicable

Not yet recruiting

• Conditions: Fatigue
• Interventions: Other: Coca-Cola; Other: Supplemental oxygen

• Registration Number: NCT06557746
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-09-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cola group	Coca-Cola	100 ml cola every 30 minutes during the operation
Oxygen group	Supplemental oxygen	Continuous supply of oxygen (2 L/min) during the operation

Primary Outcome Measures

Name	Time	Method
Attention decrease	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 Outcome Measures

Name	Time	Method
Maximal voluntary contraction force decrease	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.