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Impact of Fentanyl Analgesia on the Accuracy of HVPG Measurements in Patients With Portal Hypertension

Impact of Fentanyl Analgesia on the Accuracy of Hepatic Venous Pressure Gradient Measurements in Patients With Portal Hypertension:a Prospective, Multicenter Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04724148
Enrollment
4
Registered
2021-01-26
Start date
2022-01-01
Completion date
2024-11-01
Last updated
2023-04-25

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

Conditions

Liver Cirrhosis, Pain, Portal Hypertension

Keywords

hepatic venous pressure gradient, fentanyl

Brief summary

Portal hypertension is a common complication of chronic liver disease and is associated with most clinical consequences of cirrhosis. The most reliable method for assessing portal hypertension is the measurement of the hepatic venous pressure gradient (HVPG). The HVPG is the gold-standard methods for assessing clinically significant portal hypertension and becoming increasingly used clinically. It is useful in the differential diagnosis of portal hypertension and provides a prognostic index in cirrhotic patients. Many patients are painful and reluctant to undergo serial HVPG measurements. But interventionists are reluctant to use analgesics because they always pay more attention to the accuracy of HVPG measurements.Although Adam F. et al concluded that low-dose midazolam sedation is an option for patients undergoing serial hepatic venous pressure measurements (Hepatology 1999), the effects of using opioid analgesics alone on hepatic venous pressure measurements have not yet been defined. The objective of this study was to evaluate the effects of fentanyl on the HVPG.

Detailed description

Portal hypertension is a common complication of chronic liver disease and is associated with most clinical consequences of cirrhosis. The most reliable method for assessing portal hypertension is the measurement of the hepatic venous pressure gradient (HVPG). The HVPG is the gold-standard methods for assessing clinically significant portal hypertension and becoming increasingly used clinically. It is useful in the differential diagnosis of portal hypertension and provides a prognostic index in cirrhotic patients. Many patients are painful and reluctant to undergo serial HVPG measurements. But interventionists are reluctant to use analgesics because they always pay more attention to the accuracy of HVPG measurements. May be since it is difficult to monitor HVPG for anesthesiologist during liver surgery, there are very few and controversial studies on the effects of sedation and analgesics on HVPG. M. Susan Mandell et al concluded that desflurane alters HVPG measurements, whereas propofol did not change it (Anesth Analg 2003). However, Enric Reverter et al considered that deep sedation with propofol and remifentanil adds substantial variability and uncertainty to HVPG measurements (Liver International 2013). Although Adam F. et al concluded that low-dose midazolam sedation is an option for patients undergoing serial hepatic venous pressure measurements (Hepatology 1999), the effects of using opioid analgesics alone on hepatic venous pressure measurements have not yet been defined. The objective of this study was to evaluate the effects of fentanyl on the HVPG measurements.

Interventions

DRUGFentanyl

To assess the accuracy of HVPG in TIPS after injecting a dose of 1\ 2 mg/kg fentanyl.

Sponsors

LanZhou University
CollaboratorOTHER
Lishui hospital of Zhejiang University
CollaboratorUNKNOWN
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with cirrhosis and portal hypertension undergoing elective TIPS placement * ASAⅠ\ Ⅲ

Exclusion criteria

* Patients with portal vein thrombosis and vein-to-vein communications * Refusal of consent * Presence of allergy to fentanyl

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of HVPG1~2 hoursTo assess whether fentanyl would affect the accuracy of hepatic venous pressure gradient measurements in patients with cirrhosis.

Countries

China

Contacts

Primary ContactXiaolong Qi, MD
qixiaolong@vip.163.com+8618588602600
Backup ContactHaijun Zhang, MD
zhanghj19@lzu.edu.cn+8618215160461

Outcome results

None listed

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