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

Sponsor
Jiaolin Ning,MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT04109859
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
21.7
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Jan 21, 2021
Anticipated Study Completion Date :
Jan 21, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute physiology and chronic health evaluation IIScore sheet [3 days]

      use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China ChongQing Chongqing China 400038

    Sponsors and Collaborators

    • Jiaolin Ning,MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiaolin Ning,MD, Professor of department of anesthesia, Southwest Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04109859
    Other Study ID Numbers:
    • KY201999
    First Posted:
    Sep 30, 2019
    Last Update Posted:
    Oct 1, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Jaundice
    Jaundice, Obstructive
    Methylene Blue

    Study Results

    No Results Posted as of Oct 1, 2019