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

April 23, 2023 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Xun Li, MD
        • Principal Investigator:
          • Xun Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Fentanyl
To assess the accuracy of HVPG in TIPS after injecting a dose of 1~2 mg/kg fentanyl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of HVPG
Time Frame: 1~2 hours
To assess whether fentanyl would affect the accuracy of hepatic venous pressure gradient measurements in patients with cirrhosis.
1~2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

The First Affiliated Hospital with Nanjing Medical University
LanZhou University
Zhejiang University
Lishui hospital of Zhejiang University

Investigators

  • Study Chair: Xun Li, MD, LanZhou University
  • Study Director: Haijun Zhang, MD, LanZhou University
  • Study Director: Lei Li, MD, LanZhou University
  • Principal Investigator: Zhongwei Zhao, MD, Lishui Hospital of Zhejiang University
  • Principal Investigator: Jiansong Ji, PHD, Lishui Hospital of Zhejiang University
  • Principal Investigator: Chuan guang Wang, Master, Lishui Hospital of Zhejiang University
  • Principal Investigator: Wei Wu, Lishui Hospital of Zhejiang University
  • Principal Investigator: Lili Yang, Lishui Hospital of Zhejiang University
  • Principal Investigator: Yulan Li, MD, LanZhou University
  • Principal Investigator: YuJiang Yin, LanZhou University
  • Principal Investigator: Wei Yang, master, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Zi Niu Yu, MD, Zhejiang University
  • Principal Investigator: Wentao Wu, master, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Xujun Yang, master, LanZhou University
  • Principal Investigator: Shuangxi Li, LanZhou University
  • Principal Investigator: Fangyu Xu, LanZhou University
  • Principal Investigator: Weizhong Zhou, MD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fentanyl and HVPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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