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

Phase 1

• Conditions: Jaundice
• Interventions: Drug: Methylene Blue; Drug: Saline

• Registration Number: NCT04109859
• Lead Sponsor: Jiaolin Ning,MD

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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-28
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-10-01
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylene blue group	Methylene Blue	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).
Placebo group	Saline	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).

Primary Outcome Measures

Name	Time	Method
Acute physiology and chronic health evaluation IIScore sheet	3 days	use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71

Trial Locations

Locations (1)

department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China; 🇨🇳 ChongQing, Chongqing, China