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Completed

NCT Number: NCT02038088

The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Southwest Hospital Third Military Medical University

Chongqing, Chongqing Municipality, 400000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • ASA>Ⅱ;
  • tumor patients
  • can't collaborate;

Treatment and study plan

Primary outcomes

  1. HBV-DNA

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Lu KZ

Other

Registry information

Acronym: HBV

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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