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

Jiaolin Ning,MD

Status and phase: Unknown; Phase 1

Conditions: Jaundice

Treatments: Drug: Saline; Drug: Methylene Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT04109859

KY201999

Details and patient eligibility

About

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)

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Methylene blue group

Experimental group

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).

Treatment:

Drug: Methylene Blue

Placebo group

Placebo Comparator group

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).

Treatment:

Drug: Saline