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

NCT ID: NCT04724148

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-11-01

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injecting 1~2mg/kg fentanyl intravenously.

1. Measuring HVPG after the preparation of TIPS in patients with portal hypertension;

2. Measuring HVPG again 5 minutes later after injecting 1~2mg/kg fentanyl intravenously.

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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

Interventions

Fentanyl

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Lishui hospital of Zhejiang University

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Qi

Director, Institute of Portal Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolong Qi, MD

Role: STUDY_CHAIR

LanZhou University

Xun Li, MD

Role: STUDY_CHAIR

LanZhou University

Haijun Zhang, MD

Role: STUDY_DIRECTOR

LanZhou University

Lei Li, MD

Role: STUDY_DIRECTOR

LanZhou University

Zhongwei Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Lishui hospital of Zhejiang University

Jiansong Ji, PHD

Role: PRINCIPAL_INVESTIGATOR

Lishui hospital of Zhejiang University

Chuan guang Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Lishui hospital of Zhejiang University

Wei Wu

Role: PRINCIPAL_INVESTIGATOR

Lishui hospital of Zhejiang University

Lili Yang

Role: PRINCIPAL_INVESTIGATOR

Lishui hospital of Zhejiang University

Yulan Li, MD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

YuJiang Yin

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Wei Yang, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Zi Niu Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Wentao Wu, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Xujun Yang, master

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Shuangxi Li

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Fangyu Xu

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Weizhong Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaolong Qi, MD

Role: CONTACT

qixiaolong@vip.163.com

+8618588602600 ext. +8618588602600

Haijun Zhang, MD

Role: CONTACT

zhanghj19@lzu.edu.cn

+8618215160461 ext. +8618215160461

Facility Contacts

Xun Li, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 10094948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23763484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14633521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30616313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30215362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30457484 (View on PubMed)

Other Identifiers

Fentanyl and HVPG

Identifier Type: -

Identifier Source: org_study_id