DRUG
Oxytocin
Medicines were administered in appropriate doses
Status
Completed
Phase
Not applicable
Enrollment
120
Locations
1
Results
Not posted
Publications
2
Study summary
The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is: . Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin? Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.
Postpartum hemorrhage (PPH) is one of the most important causes of perioperative maternal deaths. Oxytocin and carbetocin are the most important uterotonic agents used for PPH. Oxytocin has a half-life of 4-10 minutes (min) and can provide continuous uterotonic properties through infusion. Carbetocin, which has been used increasingly in recent years, is a synthetic analogue of oxytocin and has a strong uterotonic effect on oxytocin receptors. Oxytocin, which is used in PPH prophylaxis and management in cesarean delivery, has some maternal side effects depending on the rate of administration. These are cardiovascular effects, nausea, vomiting, headache and allergic reactions. Since it is structurally similar to vasopressin, water retention in the body and hyponatremia, convulsions and coma can be seen, although rarely. The most common cardiac effects after oxytocin administration are dose-dependent hypotension and tachycardia. Smooth muscle relaxation caused by stimulation of calcium-dependent nitrite oxide is held responsible for hypotension.\[3\] Carbetocin, a long-acting oxytocin analog, has similar side effects and further research is needed on its effectiveness. There are potential studies supporting that the oxytocinergic system affects pain perception. Oxytocin released into the central nervous system plays an important role in the transmission and modulation of pain signals. Glutamatergic activation of oxytocin in the dorsal root ganglia results in GABAergic inhibition of Aδ and C fibers that play a role in nociception. Carbetocin is also thought to have similar effects in analgesia. Although there are studies showing that carbetocin reduces postoperative analgesic use compared to oxytocin , there is no clear consensus in the literature on this subject. The studies conducted by De Bonis et al. and Gawecka et al. were guiding in designing this study. While De Bonis et al. found that carbetocin reduces analgesic consumption, Gawecka et al. could not show a significant difference between the two agents. In this study, the investigators aim to contribute to the literature by comparing the analgesic activities of oxytocin and carbetocin to observe the differences in hemodynamic and other side effects of these two agents.
Interventions
DRUG
Medicines were administered in appropriate doses
DRUG
Medicines were administered in appropriate doses
Timeline
First posted
Nov 18, 2024
Study start
Oct 4, 2024
Primary completion
Jan 7, 2025
Study completion
Jan 10, 2025
Results posted
Not reported
Registry updated
Mar 24, 2025
Outcomes
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )
Time frame · 04/10/2024-04/01/2025
analgesic consumption
amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )
Time frame · 04/10/2024-04/01/2025
intraoperative bleeding
Postoperative 24-hour Heart rate variables (/minute)
Time frame · 04/10/2024-04/01/2025
Postoperative 24-hour hemodynamic variables
Postoperative 24-hour arterial blood pressure variables (mmHg)
Time frame · 04/10/2024-04/01/2025
Postoperative 24-hour hemodynamic variables
Postoperative 24-hour oxygen saturation variables (%)
Time frame · 04/10/2024-04/01/2025
Postoperative 24-hour hemodynamic variables
Eligibility
Inclusion Criteria: * Pregnant women in the American Society of Anesthesiologists (ASA) II class, * who have had a previous uncomplicated cesarean delivery, * who are 18-45 years old and are planned to undergo elective cesarean section with spinal anesthesia technique Exclusion Criteria: * Patients who cannot use the patient controlled analgesia (PCA) device postoperatively, * have limited intellectual function * have contraindications for spinal anesthesia
Study locations
Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.
Ankara Bilkent City Hospital
Ankara, Ankara, Turkey (Türkiye)
Publications
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