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Completed

NCT Number: NCT02829333

The Effect of Anesthetic Technique on VEGF-C and PGE2

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

general anesthesia and patient controlled intravenous analgesia

Other

Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation

spinal anesthesia and continuous postoperative epidural analgesia

Other

Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation

Primary outcomes

  1. Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery

    Time frame: 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).

  2. Change of prostaglandin E2 before anesthesia and at 48 hours after surgery

    Time frame: 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 outcomes

  1. Visual analog scale (VAS) pain scores

    Time frame: at 2h, 4h, 8h, 12h, 24h and 48h after surgery

    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

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2016
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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