The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

NCT ID: NCT02038088

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HBV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

intravenous inhalational anesthesia

No interventions assigned to this group

B

intravenous anesthesia

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lu KZ

OTHER

Sponsor Role lead

Responsible Party

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Lu KZ

Southwest Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lu KZ, PhD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Southwest Hospital Third Military Medical University

Locations

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Department of Anesthesiology, Southwest Hospital Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36386418 (View on PubMed)

Other Identifiers

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LKZ-GAHBV-01

Identifier Type: -

Identifier Source: org_study_id

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