Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy
关键词
抽象
描述
All patients will have preoperative evaluation by gynecologists and anesthetists, with history taking and pelvic examination. A TVS scan will be done to determine the number, size and location of the myomas, and evaluate the myometrial free margin (the minimum thickness between the outer edge of the myoma and inner edge of the uterine serosa), which was found to be ideally ≥ 10 mm (11). Prior office diagnostic hysteroscopy will be performed for evaluation of the number, location and grade of the submucous myomas, and assessment of the endocervical canal and uterine cavity and the position of the tubal ostia in order to aid orientation. Preoperative full blood count, serum creatinine, fasting blood glucose, liver enzymes, coagulation profile ( INR), and viral markers will be done for all the patients. Monopolar resectoscopic myomectomies will be scheduled in the proliferative phase of menstrual cycle by a single experienced operator.
After induction of general anesthesia, immediately before the operation, participants will receive either 1 ml of carbetocin (100 mcg/ml) IV over 1 minute (study group) or 1 ml of sodium chloride 0.9% IV over 1 minute (control group). The procedure will be done using the available standard setup and the distending solution used will be 1.5% glycine. A drape with a fluid-collection pouch (Lingeman 3 in 1 Procedure Drape, Lingeman Medical Products, Inc., Indianapolis, IN) placed beneath the woman's buttocks will be used to collect outflow fluid escaping between the cervix and sheath to prevent spillage of irrigating fluid onto the floor. Fluid inflow and outflow will be monitored every 3-5 minutes. The outflow fluid will be measured to the nearest milliliter. The inflow and outflow volumes of the distension solution will be carefully monitored continuously during the procedure by nurses not involved in the study under the current monitoring protocol at the operating theater. The procedure would be terminated if the fluid imbalance reached 1 L.
After completing the procedure, the surgeon completed a record sheet for rating of bleeding amount and the quality of operative view. Postoperative full blood count will be done for all patients 24 hours after the procedures. Preoperative and postoperative hemoglobin and hematocrit, the need for blood transfusion, the duration of operation, any operative complications and medication adverse effects will be recorded.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 07/18/2020 |
| 提交的预估入学人数: | 07/18/2020 |
| 首次发布: | 07/22/2020 |
| 上次提交的更新: | 07/18/2020 |
| 最近更新发布: | 07/22/2020 |
| 实际学习开始日期: | 07/14/2020 |
| 预计主要完成日期: | 12/29/2021 |
| 预计完成日期: | 01/31/2022 |
状况或疾病
干预/治疗
Drug: Carbetocin group
Drug: • Control group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Carbetocin group This group will contain 20 patients having single type 0 or I submucous uterine myomas according to International Federation of Gynecology and Obstetrics classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm.After induction of general anesthesia, immediately before the operation, participants will receive either 1 ml of carbetocin (100 mcg/ml) IV over 1 minute. | Drug: Carbetocin group (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin |
| Placebo Comparator: • Control group This group will contain 20 patients having single type 0 or I submucous uterine myomas according to International Federation of Gynecology and Obstetrics classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm.After induction of general anesthesia, immediately before the operation, participants will receive either 1 ml of sodium chloride 0.9% IV over 1 minute. | Drug: • Control group Physiological solution will be used as placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Symptomatic women aged 18-45 years diagnosed by transvaginal sonography (TVS) to have single type 0 or I submucous uterine myomas according to FIGO classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm. Exclusion Criteria: - • Age < 18 or > 45 years. - Uterine septum or structural uterine abnormality (including multiple uterine fibroids and/or multiple submucous myomas) - Present or history of cervical or uterine malignancies. - Active pelvic infection. - Chronic medical diseases (cardiopulmonary, thromboembolic, hepatic, or renal diseases). - Bleeding disorders. - Patients receiving anticoagulant therapy. - Patients receiving gonadotropin-releasing hormone (GnRH) analogues. - History of adverse reaction contraindications for Carbetocin. |
结果
主要结果指标
1. intraoperative bleeding amount [Time Frame: Start with the first resectoscope myoma cut till withdrawal of hysteroscope through the cervix at the end of the procedure]
2. • Change in haemoglobin and hematocrit [Haemoglobin and hematocrit values 24 hours before myomectomy and 24 hour after myomectomy]
次要成果指标
1. • Operative time [Start with insertion of hysteroscope through the cervix ends with withdrawal of hysteroscopy through the cervix at the end of the procedure]
2. • Fluid deficit [start with insertion of hysteroscope through the cervix ends with withdrawal of hysteroscopy through the cervix at the end pf the procedure]
3. • The quality of operative view [start with the first resectoscope myoma cut till the completion of myoma resection]
