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

NCT04109859 | Unknown Phase 1

• 1 other identifier: KY201999
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Jaundice

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Methylene blue group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Saline DRUG

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

Also known as: Placebo group

Placebo group

Methylene Blue DRUG

Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

Also known as: Methylene blue group

Methylene blue group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Jiaolin Ning,MD: lead

Study Sites (1)

department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Jaundice

Interventions

Sodium Chloride; Methylene Blue

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jiaolin Ning, MD

  Professor of department of anesthesia, Southwest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of department of anesthesia

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: April 1, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)