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Status unknownNCT03406676Updated Jan 23, 2018

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

An interventional study of Methylene Blue in Obstructive Jaundice, sponsored by Southwest Hospital, China. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obstructive Jaundice

Keywords

  • Methylene blue; Peripheral vascular resistance
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Organs dysfunction(heart,lungs and etc);
  2. Mental disorders;
  3. in other clinical trial.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Methylene blue

    2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

    Drug: Methylene Blue

  • No intervention
    saline

    50ml of saline is administrated I.V before anesthesia induction.

Interventions

  • DrugMethylene Blue

    2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

    Also known as: Methylene blue injection

05

What researchers measure

Primary outcomes

  1. Peripheral vascular resistance

    the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 \~ 1200dyns / cm5)

    Time frame: through operation completion, an average of 6 hours

06

Study locations

2 of 2 sites recruiting
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
    Recruiting
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03406676
Lead sponsor
Southwest Hospital, China
Responsible party
Shuguo Zheng, MD (Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China, Southwest Hospital, China) — Principal investigator
First posted
Jan 23, 2018
Start date
Aug 1, 2017
Primary completion
Oct 30, 2018 (estimated)
Completion
Oct 30, 2018 (estimated)
Last update
Jan 23, 2018

Study contacts

Ning Jiaolin, Doctor
Contact
Njiaolin1976@126.com
0086-15808014085
Zheng ShuGuo
principal investigator · MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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