Vasopressin Versus Epinephrine in Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01861015
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : January 22, 2016
Information provided by (Responsible Party):
Taejong Song, CHA University

Brief Summary:

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 or disease Intervention/treatment Phase
Uterine Myomas Drug: Epinephrine Drug: Vasopressin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial
Study Start Date : May 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Operative blood loss [ Time Frame: Surgery date ]
    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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01861015

Korea, Republic of
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 135-081
Sponsors and Collaborators
CHA University

Responsible Party: Taejong Song, Professor, CHA University Identifier: NCT01861015     History of Changes
Other Study ID Numbers: KNC13-013
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Epinephryl borate
Arginine Vasopressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents