Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

Overview

To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

Full Title of Study: “The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 30, 2018

Detailed Description

Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

Interventions

  • Drug: Methylene Blue
    • 2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

Arms, Groups and Cohorts

  • Experimental: Methylene blue
    • 2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
  • No Intervention: saline
    • 50ml of saline is administrated I.V before anesthesia induction.

Clinical Trial Outcome Measures

Primary Measures

  • Peripheral vascular resistance
    • Time Frame: through operation completion, an average of 6 hours
    • the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 ~ 1200dyns / cm5)

Participating in This Clinical Trial

Inclusion Criteria

1. Aged between 18-60 years; 2. American Society of Anesthesiologists(ASA) grade I~III; 3. TBIL>ULN and TBA>ULN; The patients with obstructive jaundice. Exclusion Criteria:

1. Organs dysfunction(heart,lungs and etc); 2. Mental disorders; 3. in other clinical trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Southwest Hospital, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shuguo Zheng, MD, Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China – Southwest Hospital, China
  • Overall Official(s)
    • Zheng ShuGuo, Principal Investigator, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
  • Overall Contact(s)
    • Ning Jiaolin, Doctor, 0086-15808014085, Njiaolin1976@126.com

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