Back to resultsEffect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Primary Purpose
Jaundice
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Saline
Methylene Blue
Sponsored by
About this trial
This is an interventional treatment trial for Jaundice
Eligibility Criteria
Inclusion Criteria:
- 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. -
Exclusion Criteria:
- 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. -
Sites / Locations
- department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylene blue group
Placebo group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04109859
Brief Title
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Official Title
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Anticipated)
Study Completion Date
January 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiaolin Ning,MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylene blue group
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
Methylene blue group
Intervention Description
Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping
Primary Outcome Measure Information:
Title
Acute physiology and chronic health evaluation IIScore sheet
Description
use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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. -
Exclusion Criteria:
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaolin Ning, MD
Organizational Affiliation
Professor of department of anesthesia, Southwest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
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