Vasopressin Versus Epinephrine in Myomectomy

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Sponsorlar

CHA University

KLINIK SINAQ: NCT01861015

BioSeek: nct01861015

Açar sözlər

Mücərrəd

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.

Tarixlər

Son Doğrulandı:	12/31/2015
İlk təqdim:	05/20/2013
Təxmini qeydiyyat təqdim edildi:	05/21/2013
İlk Göndərmə:	05/22/2013
Son Yeniləmə Göndərildi:	01/20/2016
Son Yeniləmə Göndərildi:	01/21/2016
Həqiqi Təhsilin Başlama Tarixi:	04/30/2013
Təxmini İlkin Tamamlanma Tarixi:	02/28/2014
Təxmini İşin Tamamlanma Tarixi:	02/28/2014

Vəziyyət və ya xəstəlik

Uterine Myomas

Müdaxilə / müalicə

Drug: Epinephrine

Drug: Vasopressin

Faza

Faza 3

Qol Qrupları

Qol	Müdaxilə / müalicə
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

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	Female
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	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.

Nəticə

İlkin nəticə tədbirləri

1. Operative blood loss [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.

Vasopressin Versus Epinephrine in Myomectomy

Açar sözlər

pelvic inflammatory disease

xərçəng xəstəliyi

fibroma

leiomyoma

uşaqlıq mioması

qanaxma

qan itirmə

infertility

anemiya

ergometrine

adrenalin