Vasopressin Versus Epinephrine in Myomectomy

Uterine Myomas Clinical Trial

Official title:

Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861015
• Other study ID #: KNC13-013
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2013
• Last updated: January 21, 2016
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: January 2016
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myomas

Intervention

Drug:
• Epinephrine

• Vasopressin

Locations

Country	Name	City	State
Korea, Republic of	CHA Gangnam Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative blood loss	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.	Surgery date	No