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

NCT ID: NCT04109859

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-01-21

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.

Conditions

Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

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).

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Methylene Blue

Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

Intervention Type: DRUG

Other Intervention Names

Placebo group; Methylene blue group

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiaolin Ning,MD

OTHER

Sponsor Role: lead

Responsible Party

Jiaolin Ning,MD

Professor of department of anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiaolin Ning, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of department of anesthesia, Southwest Hospital

Locations

department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

KY201999

Identifier Type: -

Identifier Source: org_study_id