The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines
NCT ID: NCT05476575
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2021-10-28
2025-02-28
Brief Summary
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Detailed Description
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Means of hydrogen ingestion include oral, inhalation or intravenous injection. Inhalation through simple mask, nasal cannula or ventilator is most convenient way. It has been proved that low concentration of hydrogen inhalation (1%-4%) is effective and safe without causing adverse effects on hemodynamic, respiration or even data of arterial blood gas analysis. High concentration of hydrogen inhalation is proven to be harmless and is often used in diving, treating decompression sickness and preventing arterio-venous thromboembolism.
Current data suggests that microglial cells in dorsal root ganglion are activated by danger-associated molecular pattern (DAMP) through toll-like receptor response (TLR) after external insults. Lipopolysaccharides (LPS) are recognized as TLR-4 receptor agonist and data revealed that LPS is associated with significant neuroinflammation and chronic pain process. Peripheral blood monocyte cells(PBSC) could have pro- (e.g. Tumor necrosis factor-α(TNF-α)、Interleukin-6(IL-6)、Interferon-γ(INF-γ) ) and anti- inflammation (e.g. IL-4、IL-5、IL-9、IL-10) cytokines release after LPS stimulation.
Current data suggests that hydrogen-rich water ingestion could reduce inflammation and pain score in animal model. Hydrogen inhalation is associated with decrease of pro-inflammation cytokines, such as IL-1β, IL-6, TNF-α and INF-γ. Besides, hydrogen inhalation could lead to reduction of pain in rats with high level spinal cord injury.
In addition to observing the difference of pain score between groups, we could also observe the differences between pro- and anti- inflammation cytokines in PBSC after LPS stimulation in patients receiving or not receiving hydrogen inhalation. This could tell us whether the inflammation process is inhibited in cellular level by hydrogen inhalation. To our knowledge, there is no human clinical trials discussing the effect of hydrogen inhalation on chronic pain. We hope to understand the actual impact of hydrogen inhalation on post-operative pain score and inflammation. Further larger scale randomized clinical trials could be carried on based on this result.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydrogen inhalation group
Patients allocating to this group received hydrogen inhalation (4% hydrogen given via nasal cannula) with other normal intraoperative care throughout the whole procedure.
hydrogen inhalation, 4% concentration, given via nasal cannula
4% hydrogen inhalation via nasal cannula perioperatively
Traditional care group
Patients allocating to this group received traditional intraoperative care.
No interventions assigned to this group
Interventions
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hydrogen inhalation, 4% concentration, given via nasal cannula
4% hydrogen inhalation via nasal cannula perioperatively
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Sever impairment of heart, lung, kidney and liver and autoimmune disease
* Less than 20 years old or older than 75 years old
* Patient refusal
* Severe complication occurring perioperatively
* Current pregnancy
* Hemoglobin less than 10g/dL.
20 Years
75 Years
ALL
Yes
Sponsors
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Fu Jen Catholic University Hospital
OTHER
Responsible Party
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Locations
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Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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FJUH110133
Identifier Type: -
Identifier Source: org_study_id
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