Van Yuzuncu Yil University
Van, Tuşba, 65100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06956365
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Van, Tuşba, 65100, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 iu carbetosin administered to carbetocin group
Other names: Group Carbetosin
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Other names: Group Oxytocine
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.
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.
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.
Time frame: Intraoperatively every 5 minutes
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Time frame: Intraoperatively every 5 minutes
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.
Contact information is provided by the study sponsor or research team.
Baran BT Türeli, MD
CONTACT
+90 05393133865 ext. 6080
Nurettin NK Kurt, assoc.Prof.
CONTACT
+90 4322150473 ext. 6080
Yuzuncu Yil University
Other
Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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