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The Effect of Anesthetic Technique on VEGF-C and PGE2

Primary Purpose

Uterine Leiomyomas

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
general anesthesia and patient controlled intravenous analgesia
spinal anesthesia and continuous postoperative epidural analgesia
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterine Leiomyomas focused on measuring analgesia, anesthesia, leiomyomas, tumor, vascular endothelial growth factor, anesthesia technique on tumor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

  • The patients who had a history of surgery within the preceding two weeks, a history of blood transfusion and a history of coronary artery disease, any contraindication to spinal anesthesia or opioid analgesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group GA

    Group SA

    Arm Description

    22 patients receive general anesthesia and patient controlled intravenous analgesia

    22 patients receive spinal anesthesia and continuous postoperative epidural analgesia

    Outcomes

    Primary Outcome Measures

    Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery
    Blood samples were sampled before anesthesia and at 48h after surgery for the serum VEGF-C,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
    Change of prostaglandin E2 before anesthesia and at 48 hours after surgery
    Blood samples were sampled before anesthesia and at 48h after surgery for the serum PGE2,which were analyzed by using enzyme linked immunosorbent assay (ELISA).

    Secondary Outcome Measures

    Visual analog scale (VAS) pain scores
    Visual analog scale (VAS) pain scores were used to evaluate postoperative pain at 2h, 4h, 8h, 12h, 24h and 48h after surgery by the anesthetist

    Full Information

    First Posted
    July 5, 2016
    Last Updated
    January 21, 2020
    Sponsor
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02829333
    Brief Title
    The Effect of Anesthetic Technique on VEGF-C and PGE2
    Official Title
    Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to verify the effect of anesthetic technique on the change of postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy.
    Detailed Description
    Uterine leiomyomas is the most common benign tumor of uterus, the most common tumor in women as well. Like many other forms of tumor, it requires an independent blood supply to enlarge. This process, angiogenesis, is mediated by vascular endothelial growth factor C (VEGF-C) and prostaglandin E2 (PGE2). Several studies have confirmed that VEGF-C has a high level in patients with uterine leiomyomas, which has also been demonstrated that it was related to occurrence and growth of uterine leiomyomas because it's capable of promoting angiogenesis, mitogenic, and vascular permeability-enhancing activities. Also, some researchers suggested that suppression of prostaglandin synthesis (including PGE2) via cyclooxygenase type-2 (COX-2) enzyme inhibition may reduce the incidence of some tumor. The aim of this study is to verify the effect of anesthetic technique on the change of postoperative serum VEGF-C and PGE2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Leiomyomas
    Keywords
    analgesia, anesthesia, leiomyomas, tumor, vascular endothelial growth factor, anesthesia technique on tumor

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group GA
    Arm Type
    Other
    Arm Description
    22 patients receive general anesthesia and patient controlled intravenous analgesia
    Arm Title
    Group SA
    Arm Type
    Other
    Arm Description
    22 patients receive spinal anesthesia and continuous postoperative epidural analgesia
    Intervention Type
    Other
    Intervention Name(s)
    general anesthesia and patient controlled intravenous analgesia
    Intervention Description
    Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation
    Intervention Type
    Other
    Intervention Name(s)
    spinal anesthesia and continuous postoperative epidural analgesia
    Intervention Description
    Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation
    Primary Outcome Measure Information:
    Title
    Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery
    Description
    Blood samples were sampled before anesthesia and at 48h after surgery for the serum VEGF-C,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
    Time Frame
    Before anesthesia and at 48 hours after surgery
    Title
    Change of prostaglandin E2 before anesthesia and at 48 hours after surgery
    Description
    Blood samples were sampled before anesthesia and at 48h after surgery for the serum PGE2,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
    Time Frame
    Before anesthesia and at 48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Visual analog scale (VAS) pain scores
    Description
    Visual analog scale (VAS) pain scores were used to evaluate postoperative pain at 2h, 4h, 8h, 12h, 24h and 48h after surgery by the anesthetist
    Time Frame
    at 2h, 4h, 8h, 12h, 24h and 48h after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II. Exclusion Criteria: The patients who had a history of surgery within the preceding two weeks, a history of blood transfusion and a history of coronary artery disease, any contraindication to spinal anesthesia or opioid analgesia.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Anesthetic Technique on VEGF-C and PGE2

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