The Effect of Anesthetic Technique on VEGF-C and PGE2

Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas

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.

Study Overview

• Status: Completed
• Conditions: Uterine Leiomyomas
• Intervention / Treatment: Other: general anesthesia and patient controlled intravenous analgesia; Other: spinal anesthesia and continuous postoperative epidural analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Group GA; 22 patients receive general anesthesia and patient controlled intravenous analgesia	Other: general anesthesia and patient controlled intravenous analgesia; Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation
OTHER: Group SA; 22 patients receive spinal anesthesia and continuous postoperative epidural analgesia	Other: spinal anesthesia and continuous postoperative epidural analgesia; Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Before anesthesia and at 48 hours after surgery
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).	Before anesthesia and at 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 2h, 4h, 8h, 12h, 24h and 48h after surgery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (ESTIMATE): July 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: anesthesia; analgesia; tumor; vascular endothelial growth factor; leiomyomas; anesthesia technique on tumor
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Zhangyonghai001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO