The Effect of Anesthetic Technique on VEGF-C and PGE2

Uterine Leiomyomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829333
• Other study ID #: Zhangyonghai001
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomas

Intervention

Other:
• general anesthesia and patient controlled intravenous analgesia
Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation
• spinal anesthesia and continuous postoperative epidural analgesia
Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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