Vasopressin Versus Epinephrine in Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01861015
First received: May 21, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3. However, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility.

A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two categories of interventions can be identified: (a) Vascular interventions on uterine and/or ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol, sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative local injection of vasopressin causing vasospasm is most commonly used. However, there is not a wide consensus on the use of this agent because of serious side effects reported in literature. In addition, in several countries, including France and Italy, vasopressin has not been commercialized because of its potential adverse effects on cardiovascular system.

Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However, there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy. Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents during myomectomy has never been conducted. To test the hypothesis that the injections of epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the investigators performed this randomized controlled study.


Condition Intervention Phase
Uterine Myomas
Drug: Epinephrine
Drug: Vasopressin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • Operative blood loss [ Time Frame: Surgery date ] [ Designated as safety issue: No ]
    The operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epinephrine
In the epinephrine group, we used a dilute epinephrine, 0.5 mg of epinephrine ([1/2] vial of 1mg/mL) in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject.
Drug: Epinephrine
Active Comparator: Vasopressin
In the vasopressin group, a dilute vasopressin, 5 units in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject was injected.
Drug: Vasopressin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility
  • women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks)
  • women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

  • any pelvic abnormalities requiring concomitant surgery
  • the presence of pedunculated subserosal or submucosal myoma as a dominant myoma
  • the presence of myoma of maximum diameter 10 cm based on the preoperative ultrasound
  • more than 4 myomas
  • treatment of GnRH agonist or unipristal acetate within 3 months before surgery
  • an inability to understand and provide written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861015

Contacts
Contact: Taejong Song, M.D. +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of, 135-081
Contact: Taejong Song, M.D.    +81-10-4035-8405    taejong.song@gmail.com   
Sponsors and Collaborators
CHA University
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01861015     History of Changes
Other Study ID Numbers: KNC13-013
Study First Received: May 21, 2013
Last Updated: June 24, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Vasopressins
Arginine Vasopressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics

ClinicalTrials.gov processed this record on August 26, 2014