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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2025-07-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Oxytocin (Group-O)

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

Group Type ACTIVE_COMPARATOR

Group-O

Intervention Type PROCEDURE

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

Carbetocin (Group-C)

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

Group Type EXPERIMENTAL

Group-C

Intervention Type PROCEDURE

100 iu carbetosin administered to carbetocin group

Interventions

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Group-C

100 iu carbetosin administered to carbetocin group

Intervention Type PROCEDURE

Group-O

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

Intervention Type PROCEDURE

Other Intervention Names

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Group Carbetosin Group Oxytocine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes