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

NCT06956365 | Recruiting

• 1 other identifier: 2022/09-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section

Keywords

Cesarean section; Oxytocin; Carbetocin; Uterotonic; Intraoperative bleeding

Outcome Measures

Primary Outcomes (2)

• Uterine tonus

  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.

  For 30 minutes after carbetocin administration.

• Additional uterotonic drug requirement

  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.

  For 30 minutes after carbetocin administration.

Secondary Outcomes (3)

• Intraoperative bleeding

  from drug administration to the end of surgery.

• Mean Blood Pressure

  Intraoperatively every 5 minutes

• Heart Rate

  Intraoperatively every 5 minutes

Study Arms (2)

Oxytocin (Group-O)

ACTIVE COMPARATOR

Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.

Procedure: Group-O

Carbetocin (Group-C)

EXPERIMENTAL

Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered.

Procedure: Group-C

Interventions

Group-C PROCEDURE

100 iu carbetosin administered to carbetocin group

Also known as: Group Carbetosin

Carbetocin (Group-C)

Group-O PROCEDURE

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

Also known as: Group Oxytocine

Oxytocin (Group-O)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• st and 2nd caesarean sections

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, Tuşba, 65100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

O-antigen, Acinetobacter strain 90

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Şükran ŞS Sevimli, Assoc.Prof

  Van Yüzüncü Yıl University Van/Turkey

  STUDY DIRECTOR

Central Study Contacts

Nurettin NK Kurt, assoc.Prof.

CONTACT

+90 4322150473; dr.nurettinkurt@gmail.com

Baran BT Türeli, MD

CONTACT

+90 05393133865; barantureli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: May 4, 2025
• Study Start: May 14, 2024
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 10 months
• Access Criteria: The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com

Locations

TU (1)