Clinical trial NCT06956365: To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.
Official title: Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
Oxytocin
Carbetocin
Uterotonic
Intraoperative bleeding
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uterine tonus
timeFrame: For 30 minutes after carbetocin administration.
measure: Additional uterotonic drug requirement
timeFrame: For 30 minutes after carbetocin administration.
Secondary outcomes:
measure: Intraoperative bleeding
timeFrame: from drug administration to the end of surgery.
measure: Mean Blood Pressure
timeFrame: Intraoperatively every 5 minutes
measure: Heart Rate
timeFrame: Intraoperatively every 5 minutes
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yuzuncu Yil University
state: Tuşba
Study officials:
affiliation: Van Yüzüncü Yıl University Van/Turkey
name: Şükran ŞS Sevimli, Assoc.Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.