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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724148
Recruitment Status : Not yet recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
LanZhou University
Lishui hospital of Zhejiang University
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital, Zhejiang University School of Medicine
Information provided by (Responsible Party):
Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Portal Hypertension Pain Drug: Fentanyl Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Fentanyl Analgesia on the Accuracy of Hepatic Venous Pressure Gradient Measurements in Patients With Portal Hypertension：a Prospective, Multicenter Study
Estimated Study Start Date : February 20, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724148


Contacts
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Contact: Xiaolong Qi, MD +8618588602600 ext +8618588602600 qixiaolong@vip.163.com
Contact: Haijun Zhang, MD +8618215160461 ext +8618215160461 zhanghj19@lzu.edu.cn

Locations
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China, Gansu
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
LanZhou University
Lishui hospital of Zhejiang University
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital, Zhejiang University School of Medicine
Investigators
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Study Chair: Xiaolong Qi, MD LanZhou University
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 The First Affiliated Hospital, Zhejiang University School of Medicine
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
More Information
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Publications:
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. Chinese.

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Responsible Party: Xiaolong Qi, Director, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04724148    
Other Study ID Numbers: Fentanyl and HVPG
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province:
hepatic venous pressure gradient
fentanyl
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Fentanyl
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics