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

Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04109859
• Other study ID #: KY201999
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: September 2019
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive

Intervention

Drug:
• 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
• Methylene Blue
Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

Locations

Country	Name	City	State
China	department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China	ChongQing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Jiaolin Ning,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute physiology and chronic health evaluation IIScore sheet	use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71	3 days