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To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.
All cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin (Group-O) | Active Comparator | Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered. |
|
| Carbetocin (Group-C) | Experimental | Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-C | Procedure | 100 iu carbetosin administered to carbetocin group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uterine tonus | The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction. | For 30 minutes after carbetocin administration. |
| Additional uterotonic drug requirement | If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg/ml) will be administered IM by the anesthesia team and recorded. | For 30 minutes after carbetocin administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding | Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area. | from drug administration to the end of surgery. |
| Mean Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nurettin NK Kurt, assoc.Prof. | Contact | +90 4322150473 | 6080 | dr.nurettinkurt@gmail.com |
| Baran BT Türeli, MD | Contact | +90 05393133865 | 6080 | barantureli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Şükran ŞS Sevimli, Assoc.Prof | Van Yüzüncü Yıl University Van/Turkey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University | Recruiting | Van | Tuşba | 65100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27347181 | Background | He G, Li LI, Guan E, Chen J, Qin YI, Xie Y. Fentanyl inhibits the progression of human gastric carcinoma MGC-803 cells by modulating NF-kappaB-dependent gene expression in vivo. Oncol Lett. 2016 Jul;12(1):563-571. doi: 10.3892/ol.2016.4619. Epub 2016 May 25. | |
| 35370716 | Background | Dutriez-Casteloot I, Emmanuelli V, Wiart JF, Tavernier A, Besengez C, Storme L, Houfflin-Debarge V. Long-Lasting Analgesia With Transdermal Fentanyl: A New Approach in Rat Neonatal Research. Front Pharmacol. 2022 Mar 17;13:798011. doi: 10.3389/fphar.2022.798011. eCollection 2022. |
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Study protocol anda statistical analysis plan will be share with other researchers
10 months
The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| C106365 | O-antigen, Acinetobacter strain 90 |
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In 80 pregnant patients scheduled for elective cesarean section, patients will be randomly assigned to receive 5 IU oxytocin or 100 μg carbetocin IV bolus intraoperatively after the birth of the baby.
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| Group-O | Procedure | In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered. |
|
|
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
| Intraoperatively every 5 minutes |
| Heart Rate | Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method. | Intraoperatively every 5 minutes |
| 29936450 | Background | Clemensen J, Rasmussen LV, Abelson KSP. Transdermal Fentanyl Solution Provides Long-term Analgesia in the Hind-paw Incisional Model of Postoperative Pain in Male Rats. In Vivo. 2018 Jul-Aug;32(4):713-719. doi: 10.21873/invivo.11299. |