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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04109859
Enrollment
64
Registered
2019-09-30
Start date
2019-04-01
Completion date
2021-01-21
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice

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.

Interventions

DRUGSaline

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

DRUGMethylene Blue

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

Sponsors

Jiaolin Ning,MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Acute physiology and chronic health evaluation IIScore sheet3 daysuse this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026