Vasopressin Versus Epinephrine in Myomectomy
Primary Purpose
Uterine Myomas
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epinephrine
Vasopressin
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Myomas
Eligibility 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.
Sites / Locations
- CHA Gangnam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epinephrine
Vasopressin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01861015
Brief Title
Vasopressin Versus Epinephrine in Myomectomy
Official Title
Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epinephrine
Arm Type
Experimental
Arm Description
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.
Arm Title
Vasopressin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Primary Outcome Measure Information:
Title
Operative blood loss
Description
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.
Time Frame
Surgery date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHA Gangnam Medical Center
City
Seoul
ZIP/Postal Code
135-081
Country
Korea, Republic of
12. IPD Sharing Statement
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Vasopressin Versus Epinephrine in Myomectomy
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