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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue
• Intervention / Treatment: Other: Coca-Cola; Other: Supplemental oxygen

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 Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Wu, M.D.; Phone Number: 8618612671010; Email: wudong@pumch.cn
• Study Contact Backup: Name: Haifeng Xu, M.D.; Email: xuhf781120@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cola group; 100 ml cola every 30 minutes during the operation	Other: Coca-Cola; 100 ml Coca-Cola every 30 minutes during the operation
Experimental: Oxygen group; Continuous supply of oxygen (2 L/min) during the operation	Other: Supplemental oxygen; Continuous supply of oxygen (2 L/min) during the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention decrease	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.	30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal voluntary contraction force decrease	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.	30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Tibet Autonomous Region People's Hospital
• Investigators: Study Chair: Dong Wu, M.D., Tibet Autonomous Region People's Hospital; Study Chair: Haifeng Xu, M.D., Tibet Autonomous Region People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Coca-Cola; Supplemental oxygen; Surgeon Fatigue
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: ME-TBHP-24-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No