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

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 Overview

• Status: Unknown
• Conditions: Jaundice
• Intervention / Treatment: Drug: Methylene Blue; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • ChongQing, Chongqing, China, 400038
      • department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Methylene Blue; Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping; Other Names: Methylene blue group
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).	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; Other Names: Placebo group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiaolin Ning,MD
• Investigators: Principal Investigator: Jiaolin Ning, MD, Professor of department of anesthesia, Southwest Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): January 21, 2021
• Study Completion (ANTICIPATED): January 21, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice; Jaundice, Obstructive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: KY201999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No