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

Yuzuncu Yıl University

Status: Enrolling

Conditions: Cesarean Section

Treatments: Procedure: Group-C; Procedure: Group-O

Study type: Interventional

Funder types: Other

Identifiers

NCT06956365

2022/09-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Oxytocin (Group-O)

Active Comparator group

Description:

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

Treatment:

Procedure: Group-O

Carbetocin (Group-C)

Experimental group

Description:

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

Treatment:

Procedure: Group-C