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
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
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
NCT ID
NCT02829333
First Posted
July 5, 2016
Last Updated
January 21, 2020
Sponsor
General Hospital of Ningxia Medical University
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
Learn more about this trial
The Effect of Anesthetic Technique on VEGF-C and PGE2
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