Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota
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狀態招聘中
贊助商
National Taiwan University Hospital
臨床試驗: NCT04079673
BioSeek: nct04079673
關鍵詞
抽象
As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.
The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.
Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.
日期
最後驗證: | 07/31/2019 |
首次提交: | 09/02/2019 |
提交的預估入學人數: | 09/02/2019 |
首次發布: | 09/05/2019 |
上次提交的更新: | 09/30/2019 |
最近更新發布: | 10/01/2019 |
實際學習開始日期: | 09/29/2019 |
預計主要完成日期: | 11/29/2021 |
預計完成日期: | 12/30/2021 |
狀況或疾病
Living Donor Hepatectomy
干預/治療
Procedure: Patient controlled epidural analgesia
Drug: Intravenous patient controlled analgesia
相
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手臂組
臂 | 干預/治療 |
---|---|
Active Comparator: Patient controlled epidural analgesia Use of patient controlled epidural analgesia (PCEA) for postoperative pain control | Procedure: Patient controlled epidural analgesia Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control |
Sham Comparator: Intravenous patient controlled analgesia Use of intravenous patient controlled analgesia(IVPCA) for postoperative pain control | Drug: Intravenous patient controlled analgesia Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control |
資格標準
有資格學習的年齡 | 20 Years 至 20 Years |
有資格學習的性別 | All |
接受健康志願者 | 是 |
標準 | Inclusion Criteria: 1. Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old. Exclusion Criteria: 1. Previous use of antibiotics within four weeks. 2. Previous gastrointestinal surgery. |
結果
主要結果指標
1. Microbiota analysis [one month]
16S metagenomic sequence processing
次要成果指標
1. LPS-binding protein [one month]
LPS-binding protein(mcg/mL)
2. Intestinal fatty acid binding protein [one month]
Intestinal fatty acid binding protein(ng/mL)
3. IgA [one month]
IgA(mcg/mL)
4. IL-6 [one month]
IL-6(ng/mL)
5. I-FEED scoring [one week]
I-FEED scoring system for postoperative gastrointestinal function:
Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3)
Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3)
Emesis(score): none(0), ≧1 episode of low volume(<100mL) and none bilious(1), ≧1 episode of high volume(>100mL) or bilious(3)
Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3)
Duration of symptoms(score):0-24hours(0),24-72hours(1),>72hours(2)
Total score: 0-2 normal, 3-5 postoperative GI intolerance, >6 postoperative GI dysfunction