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

Primary Purpose

Obstructive Jaundice

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methylene Blue
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstructive Jaundice focused on measuring Methylene blue; Peripheral vascular resistance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Southwest HospitalRecruiting
  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Methylene blue

saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2018
Last Updated
January 22, 2018
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03406676
Brief Title
Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance
Official Title
The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice
Keywords
Methylene blue; Peripheral vascular resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylene blue
Arm Type
Experimental
Arm Description
2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
Arm Title
saline
Arm Type
No Intervention
Arm Description
50ml of saline is administrated I.V before anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
Methylene blue injection
Intervention Description
2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
Primary Outcome Measure Information:
Title
Peripheral vascular resistance
Description
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

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: Aged between 18-60 years; American Society of Anesthesiologists（ASA） grade I~III; TBIL>ULN and TBA>ULN; The patients with obstructive jaundice. Exclusion Criteria: Organs dysfunction(heart,lungs and etc); Mental disorders; in other clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Jiaolin, Doctor
Phone
0086-15808014085
Email
Njiaolin1976@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng ShuGuo
Organizational Affiliation
MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Jiaolin
Phone
0086-15808014085
Email
Njiaolin1976@126.com
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Jiaolin, Doctor
Phone
0086-15808014085
Email
Njiaolin1976@126.com

12. IPD Sharing Statement

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

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