Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

Study Overview
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Brief Summary
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Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO)

Detailed Description
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The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO. Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.

Official Title
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Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

Conditions
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Jaundice

Intervention / Treatment
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* Drug: Saline
* Drug: Methylene Blue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 70 years old; ASA grade I III; Ability to comply with research protocols; Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L; Voluntarily participate in the study and sign the informed consent form. - Exclusion Criteria: ASA IV V grade; women during lactation and pregnancy; Patients with severe heart disease or lung disease before surgery; Participating in other trials in the last 2 months; Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly; Those who refuse to sign the informed consent form. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylene blue group<br>Before the anesthesia was intubated, the patients in the methylene blue group were given a 2 mg/Kg methylene blue 50 ml intravenously for 10 min; continuous constant speed pumping methylene blue(0.5mg/Kg/h). | Drug: Methylene Blue<br>* Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping<br>* Other names: Methylene blue group;|
| Placebo Comparator: Placebo group<br>Before the anesthesia was intubated, the placebo group was given 50 ml of normal saline for 10 min.continuous constant speed pumpingnormal saline (10ml/h). | Drug: Saline<br>* When using saline, if found mean arterial pressure <65mmHg, Cardic Output>4L/min, Sequential Vascular Response<800 (dyne×sec)/cm, starting dose of norepinephrine 0.04ug/min/kg<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute physiology and chronic health evaluation IIScore sheet | use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71 | 3 days |