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临床试验/NCT06692621
NCT06692621已完成不适用

Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who cannot use the patient controlled analgesia (PCA) device postoperatively,
  • have limited intellectual function
  • have contraindications for spinal anesthesia

研究组 & 干预措施

O:oxytocin

In the oxytocin group, oxytocin ('Synpitan forte 5 IU/ml im/iv ampoule, Deva İlaç Sanayi, Turkey)' was administered 20 IU intravenously (5 IU intravenous bolus followed by 15 IU/hour infusion) in accordance with the recommendations of the Ministry of Health of the Republic of Turkey.

干预措施: Oxytocin (Drug)

C:carbetocin

In the carbetocin group, carbetocin 'Pabal 100 microgram/ml iv solution for injection ampoule, Ferring GmbH, Germany) was diluted with 20 ml of 0.9% NaCl solution and administered over 30-60 seconds.

干预措施: Carbetocin (Drug)

结局指标

主要结局

Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )

时间窗: 04/10/2024-04/01/2025

analgesic consumption

次要结局

  • amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )(04/10/2024-04/01/2025)
  • Postoperative 24-hour Heart rate variables (/minute)(04/10/2024-04/01/2025)
  • Postoperative 24-hour arterial blood pressure variables (mmHg)(04/10/2024-04/01/2025)
  • Postoperative 24-hour oxygen saturation variables (%)(04/10/2024-04/01/2025)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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