To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group-C, Group-O.
- Who it may be relevant to
- Registry conditions: Cesarean Section. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
Overview
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
- Procedure Group-C
100 iu carbetosin administered to carbetocin group - Procedure Group-O
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Primary outcome measures
- Uterine tonus [Time frame: For 30 minutes after carbetocin administration.]
- Additional uterotonic drug requirement [Time frame: For 30 minutes after carbetocin administration.]
Secondary outcome measures (3)
- Intraoperative bleeding [Time frame: from drug administration to the end of surgery.]
- Mean Blood Pressure [Time frame: Intraoperatively every 5 minutes]
- Heart Rate [Time frame: Intraoperatively every 5 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Van Yuzuncu Yil University — Van
Publications
- 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 27347181
- 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 35370716
- 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. PMID 29936450
Identifiers
NCT: NCT06956365 · 2022/09-10