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NCT Number: NCT06956365

To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.

To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, Tuşba, 65100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Şükran ŞS Sevimli, MD

CONTACT

[email protected]

+90 5445262921

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group-C

Procedure

100 iu carbetosin administered to carbetocin group

Other names: Group Carbetosin

Group-O

Procedure

In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.

Other names: Group Oxytocine

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. Mean Blood Pressure

    Time frame: Intraoperatively every 5 minutes

    Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.

  3. Heart Rate

    Time frame: Intraoperatively every 5 minutes

    Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.

Study contacts

Contact information is provided by the study sponsor or research team.

Baran BT Türeli, MD

CONTACT

[email protected]

+90 05393133865 ext. 6080

Nurettin NK Kurt, assoc.Prof.

CONTACT

[email protected]

+90 4322150473 ext. 6080

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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