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| Name | Class |
|---|---|
| Tibet Autonomous Region People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cola group | Experimental | 100 ml cola every 30 minutes during the operation |
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| Oxygen group | Experimental | Continuous supply of oxygen (2 L/min) during the operation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coca-Cola | Other | 100 ml Coca-Cola every 30 minutes during the operation |
| |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wu, M.D. | Contact | 8618612671010 | wudong@pumch.cn | |
| Haifeng Xu, M.D. | Contact | xuhf781120@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wu, M.D. | Tibet Autonomous Region People's Hospital | Study Chair |
| Haifeng Xu, M.D. | Tibet Autonomous Region People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22824853 | Background | 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. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Stepped-wedge cluster randomized controlled trial
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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.
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| Supplemental oxygen |
| Other |
Continuous supply of oxygen (2 L/min) during the operation |
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| 30 minutes before the surgery; end of the surgery; (the duration depends on the surgery complexity, at least 2 hours) |