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

NCT ID: NCT03406676

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-10-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methylene blue

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

Group Type EXPERIMENTAL

Methylene Blue

Intervention Type DRUG

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

saline

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methylene Blue

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

Intervention Type DRUG

Other Intervention Names

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Methylene blue injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Shuguo Zheng, MD

Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zheng ShuGuo

Role: PRINCIPAL_INVESTIGATOR

MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Jiaolin, Doctor

Role: CONTACT

0086-15808014085

Facility Contacts

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Ning Jiaolin

Role: primary

0086-15808014085

Ning Jiaolin, Doctor

Role: primary

0086-15808014085

Other Identifiers

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MZK002

Identifier Type: -

Identifier Source: org_study_id

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