The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02038088

Acronym

HBV

Enrollment

Registered

2014-01-16

Start date

2014-01-31

Completion date

2015-01-31

Last updated

2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV Infection

Keywords

Need general anesthesia

Brief summary

The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication

Detailed description

The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ; 2. ability to compliance the research plan; 3. volunteered and signed for the study ; 4. 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); 5. receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).

Exclusion criteria

1. ASA\>Ⅱ; 2. tumor patients 3. can't collaborate;

Design outcomes

Primary

Measure	Time frame	Description
HBV-DNA	with in the first 5 days after surgery	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 .

Countries

China

Outcome results