PROCEDURE
Group-C
100 iu carbetosin administered to carbetocin group
To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.
Status
Recruiting
Phase
Not applicable
Enrollment
80
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
Full 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
Treatment arms and agents.
PROCEDURE
Group-O
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Timeline
From registration to results.
First posted
May 4, 2025
Study start
May 14, 2024
Primary completion
May 30, 2025
Study completion
Jul 30, 2025
Results posted
Not reported
Registry updated
May 4, 2025
Outcomes
What the study measures.
Primary outcomes
Uterine tonus
Time frame · 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
Time frame · 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 outcomes
Intraoperative bleeding
Time frame · 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
Time frame · Intraoperatively every 5 minutes
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Heart Rate
Time frame · Intraoperatively every 5 minutes
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Sex
- FEMALE
- 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
Study locations
1 registered sites.
Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.
Van Yuzuncu Yil University
Van, Tuşba, Turkey (Türkiye)
Publications
Results and literature.
PMID 27347181 ↗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.PMID 35370716 ↗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.PMID 29936450 ↗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.
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