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

NCT06557746 | Not Yet Recruiting DMC

• 1 other identifier: ME-TBHP-24-019
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue

Keywords

Surgeon Fatigue; Supplemental oxygen; Coca-Cola

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Cola group

EXPERIMENTAL

100 ml cola every 30 minutes during the operation

Other: Coca-Cola

Oxygen group

EXPERIMENTAL

Continuous supply of oxygen (2 L/min) during the operation

Other: Supplemental oxygen

Interventions

Coca-Cola OTHER

100 ml Coca-Cola every 30 minutes during the operation

Cola group

Supplemental oxygen OTHER

Continuous supply of oxygen (2 L/min) during the operation

Oxygen group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Tibet Autonomous Region People's Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 22824853 BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Wu, M.D.

  Tibet Autonomous Region People's Hospital

  STUDY CHAIR

• Haifeng Xu, M.D.

  Tibet Autonomous Region People's Hospital

  STUDY CHAIR

Central Study Contacts

Dong Wu, M.D.

CONTACT

8618612671010; wudong@pumch.cn

Haifeng Xu, M.D.

CONTACT

xuhf781120@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: Stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share