The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication
HBV
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 13, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJanuary 28, 2015
January 1, 2015
7 months
January 13, 2014
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBV-DNA
collect blood samples 4 times with in the first 5 days after surgery: the first time：before initiation of anesthesia; the second time：the first day after surgery; the third time：the third day after surgery; the forth time：the fifth day after surgery. And outcome measure will be assessed with in 3 months when all the samples collected, and will be presented with in 2 months when outcome measure assessed .
with in the first 5 days after surgery
Study Arms (2)
A
intravenous inhalational anesthesia
B
intravenous anesthesia
Eligibility Criteria
patients with HBV infection receive surgery under general anesthesia
You may qualify if:
- American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- ability to compliance the research plan;
- volunteered and signed for the study ;
- HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%\>71, forced expiratory volume at one second（FEV1.0）%\>61, arterial oxygen saturation（SaO2）%\>94, arterial partial pressure of oxygen（PaO2）\>75 mmHg, arterial carbondioxide partial pressure（PaCO2）\<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3);
- receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).
You may not qualify if:
- ASA\>Ⅱ;
- tumor patients
- can't collaborate;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lu KZlead
Study Sites (1)
Department of Anesthesiology, Southwest Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400000, China
Related Publications (1)
Quan J, Chen X, Tang X, Liu X, Li J, Yi B, Li P, Lu K, Gu J. Effects of General Anesthesia on Changes of Serum Hepatitis B Virus-DNA Levels in Infected Patients Underwent Non-Hepatobiliary Minimally Invasive Surgery: A Pilot Observational Study. Infect Drug Resist. 2022 Nov 11;15:6631-6640. doi: 10.2147/IDR.S379350. eCollection 2022.
PMID: 36386418DERIVED
Biospecimen
serum
Study Officials
- STUDY DIRECTOR
Lu KZ, PhD
Department of Anesthesiology, Southwest Hospital Third Military Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Southwest Hospital
Study Record Dates
First Submitted
January 13, 2014
First Posted
January 16, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
January 1, 2015
Last Updated
January 28, 2015
Record last verified: 2015-01