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

Overview

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)

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 21, 2021

Detailed Description

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.

Interventions

  • Drug: Saline
    • 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
  • Drug: Methylene Blue
    • Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

Arms, Groups and Cohorts

  • Experimental: Methylene blue group
    • 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).
  • Placebo Comparator: Placebo group
    • 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).

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 18~70 years old; 2. ASA grade I~III; 3. Ability to comply with research protocols; 4. Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L; 5. Voluntarily participate in the study and sign the informed consent form. - Exclusion Criteria:

1. ASA IV~V grade; 2. women during lactation and pregnancy; 3. Patients with severe heart disease or lung disease before surgery; 4. Participating in other trials in the last 2 months; 5. Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly; 6. Those who refuse to sign the informed consent form. -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiaolin Ning,MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jiaolin Ning,MD, Professor of department of anesthesia – Southwest Hospital, China
  • Overall Official(s)
    • Jiaolin Ning, MD, Principal Investigator, Professor of department of anesthesia, Southwest Hospital

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