Plain English Summary
Background and study aims
Hepatitis is a disease where the liver becomes inflamed (swollen), and is generally caused by a viral infection or long-term alcohol abuse. Hepatitis C is the most common type of viral hepatitis. In an infected person, the hepatitis C virus is particularly concentrated in the blood, and so it can is easily spread through blood-to-blood contact, such as sharing needles amongst drug abusers or receiving contaminated blood products in hospital. In the early stages (acute hepatitis) a person often has no symptoms, and so does not know that they are infected. This means that about 80% of infections are able to move to the long-lasting stage. Chronic hepatitis C (CHC) is where a person has been infected for more than six months. Sufferers tend to feel extremely tired, achy and generally unwell. Left untreated, the infection causes the liver to become irreversibly scarred (cirrhosis) leading to liver failure. People suffering from hepatitis C are also prone to other medical problems. Gallstones (solid lumps that develop from substances in the gallbladder) are very common in cirrhotic patients. Gallstones can be very painful and sometimes it is necessary to surgically remove the gallbladder (laparoscopic cholecystectomy). Patients with CHC are considered to have a greater risk of developing complications from surgery than the general population. The level of risk is determined using a scale called the Childs-Pugh score, where class A patients are very likely to survive and class B and C are less so. General anaesthesia (sedation) also puts patients at risk, as some of the drugs commonly used can be toxic to the liver and kidneys. More research is therefore needed to find the safest anaesthetic to use in surgery for patients with CHC. The aim of this study is to compare the effects of sevoflurane and desflurane (two inhalable anaesthetics) on liver and kidney function in CHC patients having a laparoscopic cholecystectomy.
Who can participate?
Adults with hepatitis C graded as class A using the Childs-Pugh score, who are scheduled for a laparoscopic cholecystectomy.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are sedated using sevoflurane and oxygen during their surgery, and the second group are sedated using desflurane and oxygen. Both drugs are given in the form of an inhalation anaesthetic (to be breathed in through a face mask) in their surgery for up to 2 hours. Participants have blood samples taken after their surgery, and then again after 1 and 3 days in order to test how well their liver and kidneys are working. The amount of the hepatitis C virus in the blood is also measured after the surgery and 3 days later.
What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part; however their participating could help to improve the way future patients are treated. The risks of participating include the general risks associated with having a laparoscopic cholecystectomy and being sedated using a general anaesthetic.
Where is the study run from?
1. Kasr Al-Aini Teaching Hospital (Egypt)
2. Theodor Bilharz Research Institute (Egypt)
When is the study starting and how long is it expected to run for?
July 2015 May 2016
Who is funding the study?
Theodor Bilharz Research Institute (Egypt)
Who is the main contact?
Professor Hala Goma
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hala Goma
ORCID ID
http://orcid.org/0000-0001-7800-8115
Contact details
21 Elgaber Sreest Giza
Elgeza
12111
Egypt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of low flow sevonflurane versus low flow desflurane anesthesia on hepatic and renal functions in hepatitis C positive patients undergoing laparoscopic cholecystectomy surgery
Acronym
Study hypothesis
The aim of this study is to follow up the effect of low flow Sevoflurane versus desfluraneanesthesia on renal and liver function, and if the hepatic affectionis associated with increase in viral replication in HCV positive class A (Childs-Hugh score) patients undergoing laparoscopic cholecystectomy.
Ethics approval
Institutional Review Board of Theodor Bilharz Research Institute, 17/06/2015, ref: FWA 0001609
Study design
Multi-centre single-blinded randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Hepatitis C
Intervention
Participants are randomly allocated to one of two groups:
Group 1: Participants are treated using seveoflurane at a concentration of (1.0 ±0.2 MAC) as inhalation anesthestic with 100% oxygen for anesthesia for up to 2 hours during their laparoscopic cholecystectomy surgery. Total fresh gas flow of 5L/min, for up to 2 hours.
Group 2: Participants are treated using desflurane at a concentration of (1.0 ±0.2 MAC) between 40 and 60 minutes during their laparoscopic cholecystectomy surgery. Total fresh gas flow of 5L/min, for up to 2 hours.
Following surgery, blood samples are taken to measure liver and kidney function, as well as Hepatitis C viral RNA. The blood tests are repeated after 1 and 3 days postoperative.
Intervention type
Drug
Phase
Drug names
1. Seveoflurane
2. Desflurane
Primary outcome measures
1. Liver function is determined by measuring AST, ALT and alkaline phosphate in the blood postoperative, 1 day and 3 days postoperative
2. Kidney function is determined by measuring urea and creatinine in the blood postoperative, 1 day and 3 days postoperative
Secondary outcome measures
Hepatitis C viral RNA is measured using blood testing preoperative and 3 days postoperative.
Overall trial start date
30/07/2015
Overall trial end date
30/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 20-60 years
2. Hepatitis C virus positive
3. Grade A patients (Child-Pugh classification of liver disease) with liver enzymes below double fold of normal reference range
4. Scheduled for laparoscopic cholecystectomy surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Grade B or C (Child-Pugh classification of liver disease) or with liver enzymes [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than double fold of normal reference range
2. BMI over 30
3. Choronic renal disease and renalinsufficiency (creatinine>1,5 mg dl-1)
4. Use of alcohol or drugs
5. Diabetes Mellitus
6. Hypertenion
7. Unstable angina pectoris
8. History of myocardial infarction within the last 6 months
Recruitment start date
01/08/2015
Recruitment end date
01/04/2016
Locations
Countries of recruitment
Egypt
Trial participating centre
Kasr Al-Aini Teaching Hospital
27 Nafezet Sheem El Shafaey Street
Kasr El Ainy
Cairo
11562
Egypt
Trial participating centre
Theodor Bilharz Research Institute
El Nile Street
Warrak El Hadar
Giza
12411
Egypt
Sponsor information
Organisation
Theodor bilharz insitute
Sponsor details
Kornish El-Nile
WarakEl-Hadar
Imbaba 30
Giza
12411
Egypt
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Theodor Bilharz Research Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of results in a peer reviewed journal.
Intention to publish date
30/05/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary