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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724148
• Other study ID #: Fentanyl and HVPG
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Xiaolong Qi, MD
• Phone: +8618588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with cirrhosis and portal hypertension undergoing elective TIPS placement

• ASA?~?

Exclusion Criteria:

• Patients with portal vein thrombosis and vein-to-vein communications

• Refusal of consent

• Presence of allergy to fentanyl

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Pain
• Portal Hypertension

Intervention

Drug:
• Fentanyl
To assess the accuracy of HVPG in TIPS after injecting a dose of 1~2 mg/kg fentanyl.

Locations

Country	Name	City	State
China	The First Hospital of Lanzhou University	Lanzhou	Gansu

Sponsors (5)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province	LanZhou University, Lishui hospital of Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (6)

Chinese Portal Hypertension Diagnosis and Monitoring Study Group (CHESS); Minimally Invasive Intervention Collaborative Group, Chinese Society of Gastroenterology; Emergency Intervention Committee, Chinese College of Interventionalists; Hepatobiliary Diseases Collaborative Group, Chinese Society of Gastroenterology; Spleen and Portal Hypertension Group, Chinese Society of Surgery; Fatty Liver and Alcoholic Liver Disease Group, Chineses Society of Hepatology; Chinese Research Hospital Association for the Study of the Liver; Hepatobiliary and Pancreatic Diseases Prevention and Control Committee, Chinese Preventive Medicine Association; Chinese Society of Digital Medicine; Chinese Society of Clinical Epidemiology and Evidence Based Medicine. [Consensus on clinical application of hepatic venous pressure gradient in China (2018)]. Zhonghua Gan Zang Bing Za Zhi. 2018 Nov 20;26(11):801-812. doi: 10.3760/cma.j.issn.1007-3418.2018.11.001. No abstract available. Chinese. — View Citation

Mandell MS, Durham J, Kumpe D, Trotter JF, Everson GT, Niemann CU. The effects of desflurane and propofol on portosystemic pressure in patients with portal hypertension. Anesth Analg. 2003 Dec;97(6):1573-1577. doi: 10.1213/01.ANE.0000090741.63156.1B. — View Citation

Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20. — View Citation

Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. — View Citation

Reverter E, Blasi A, Abraldes JG, Martinez-Palli G, Seijo S, Turon F, Berzigotti A, Balust J, Bosch J, Garcia-Pagan JC. Impact of deep sedation on the accuracy of hepatic and portal venous pressure measurements in patients with cirrhosis. Liver Int. 2014 Jan;34(1):16-25. doi: 10.1111/liv.12229. Epub 2013 Jun 13. — View Citation

Steinlauf AF, Garcia-Tsao G, Zakko MF, Dickey K, Gupta T, Groszmann RJ. Low-dose midazolam sedation: an option for patients undergoing serial hepatic venous pressure measurements. Hepatology. 1999 Apr;29(4):1070-3. doi: 10.1002/hep.510290421. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of HVPG	To assess whether fentanyl would affect the accuracy of hepatic venous pressure gradient measurements in patients with cirrhosis.	1~2 hours