FatigueCOMETSNCT06557746
Coca-Cola vs. Oxygen for Fatigue Management in Tibet Surgeons
A study testing Coca-Cola and Supplemental oxygen in people with Fatigue, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Coca-Cola and Supplemental oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Haifeng Xu, M.D. contact
About this study
Official title: 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.
Read the 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
- Fatigue
- Being tested
- Coca-Cola, Supplemental oxygen
- Keywords
- Surgeon Fatigue, Supplemental oxygen, Coca-Cola
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coca-ColaOther
100 ml Coca-Cola every 30 minutes during the operation
Supplemental oxygenOther
Continuous supply of oxygen (2 L/min) during the operation
| Study group | Role | What they receive |
|---|---|---|
| Cola group | Experimental | 100 ml cola every 30 minutes during the operation Receives: Other: Coca-Cola |
| Oxygen group | Experimental | Continuous supply of oxygen (2 L/min) during the operation Receives: Other: Supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Secondary outcomes (1)
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.
Measured: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Responsible party
- Principal investigator, DONG WU, Tibet Autonomous Region People's Hospital
- Investigators
- Dong Wu, M.D., Study chair, Tibet Autonomous Region People's HospitalHaifeng Xu, M.D., Study chair, Tibet Autonomous Region People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557746
- Sponsor's protocol ID
- ME-TBHP-24-019
- Acronym
- COMETS
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22824853
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coca-Cola Versus Supplemental Oxygen on Fatigue Management in Tibet Surgeons
- ClinicalTrials.gov ID
- NCT06557746
- Acronym / sponsor ID
- COMETS / ME-TBHP-24-019
- Conditions
- Fatigue
- Keywords
- Surgeon Fatigue, Supplemental oxygen, Coca-Cola
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cola group | Experimental | Other: Coca-Cola100 ml cola every 30 minutes during the operation |
| Oxygen group | Experimental | Other: Supplemental oxygenContinuous supply of oxygen (2 L/min) during the operation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coca-Cola100 ml Coca-Cola every 30 minutes during the operation | Other | Cola group |
| Supplemental oxygenContinuous supply of oxygen (2 L/min) during the operation | Other | Oxygen group |
Primary outcome
Attention decrease
Time frame: 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.
1 secondary outcome
Maximal voluntary contraction force decrease
Time frame: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 22824853Dorion 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haifeng Xu, M.D. contact
Dong Wu, M.D. study chair
Tibet Autonomous Region People's Hospital
Haifeng Xu, M.D. study chair
Tibet Autonomous Region People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Coca-Cola and Supplemental oxygen in people with Fatigue, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wu, M.D. (8618612671010, wudong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention decrease (time frame: 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.