Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance
The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation
1 other identifier
interventional
70
1 country
2
Brief Summary
To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedJanuary 23, 2018
January 1, 2018
1.2 years
January 4, 2018
January 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral vascular resistance
the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 \~ 1200dyns / cm5)
through operation completion, an average of 6 hours
Study Arms (2)
Methylene blue
EXPERIMENTAL2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
saline
NO INTERVENTION50ml of saline is administrated I.V before anesthesia induction.
Interventions
2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
Eligibility Criteria
You may qualify if:
- Aged between 18-60 years;
- American Society of Anesthesiologists（ASA） grade I\~III;
- TBIL\>ULN and TBA\>ULN; The patients with obstructive jaundice.
You may not qualify if:
- Organs dysfunction(heart,lungs and etc);
- Mental disorders;
- in other clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zheng ShuGuo
MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China
Study Record Dates
First Submitted
January 4, 2018
First Posted
January 23, 2018
Study Start
August 1, 2017
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
January 23, 2018
Record last verified: 2018-01