The Effect of Anesthetic Technique on VEGF-C and PGE2

NCT02829333 | Completed DMC

• 1 other identifier: Zhangyonghai001
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uterine Leiomyomas

Keywords

analgesia; anesthesia; leiomyomas; tumor; vascular endothelial growth factor; anesthesia technique on tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual analog scale (VAS) pain scores

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

Study Arms (2)

Group GA

OTHER

22 patients receive general anesthesia and patient controlled intravenous analgesia

Other: general anesthesia and patient controlled intravenous analgesia

Group SA

OTHER

22 patients receive spinal anesthesia and continuous postoperative epidural analgesia

Other: spinal anesthesia and continuous postoperative epidural analgesia

Interventions

general anesthesia and patient controlled intravenous analgesia OTHER

Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation

Group GA

spinal anesthesia and continuous postoperative epidural analgesia OTHER

Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation

Group SA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

MeSH Terms

Conditions

Myofibroma; Agnosia; Leiomyoma; Neoplasms

Interventions

Anesthesia, General; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 12, 2016
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 22, 2020

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share