Cesarean Section
Conditions
Keywords
Cesarean section, Oxytocin, Carbetocin, Uterotonic, Intraoperative bleeding
Brief summary
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
Detailed description
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.
Interventions
PROCEDUREGroup-C
100 iu carbetosin administered to carbetocin group
PROCEDUREGroup-O
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for caesarean sections * Between 18-40 years * ASA I-II group * Those who will undergo general anesthesia * Those between 35-40 weeks of pregnancy * 1st and 2nd caesarean sections
Exclusion criteria
* Those who prefer spinal or epidural anesthesia * Those who are outside the age range of 18-40 * Those who are ASA III and above * Those with HT, DM, cardiac and respiratory diseases * Preeclampsia, eclampsia, HELLP * Those with a history of drug use that affects the cardiovascular system * Placenta Previa, Placenta Acreta, Placenta Acreta
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine tonus | For 30 minutes after carbetocin administration. | 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. |
| Additional uterotonic drug requirement | For 30 minutes after carbetocin administration. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding | from drug administration to the end of surgery. | Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area. |
| Mean Blood Pressure | Intraoperatively every 5 minutes | Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method. |
| Heart Rate | Intraoperatively every 5 minutes | Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactNurettin NK Kurt, assoc.Prof.
Backup ContactBaran BT Türeli, MD
Outcome results
None listed