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临床试验/NCT05511415
NCT05511415已完成不适用

In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月2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
发起方
入组人数
50
试验地点
1
主要终点
Motility index

研究概览

简要总结

Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony. Myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (CD). It has been proven that exposure to oxytocin during labor results in a decrease in myometrial contractions.

Dexmedetomidine is a drug which has been used in obstetric practice due to its desirable effects such as decreasing pain, reduced elevation in blood pressure and heart rate, sedation, and diminished anesthetic requirement. It has been used as an adjunct during spinal or epidural anesthesia during CD and even during general anesthesia for some obstetric surgeries.

The use of dexmedetomidine has been continuously rising due to its favorable effects. Its use as an adjunct in general anesthesia for obstetrical surgeries has been shown to have promising advantages. During this pandemic, dexmedetomidine has been utilized largely as a sedative in critically ill and intubated patients. This does not exclude critically ill pregnant patients who may also need to deliver urgently. Thus, it is important to investigate its effect on uterine contractility on this particular group of patients.

The investigators hypothesize that dexmedetomidine causes a dose-dependent increase in contractility of the pregnant human myometrium, both spontaneous and oxytocin-induced.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients scheduled for elective CD under regional anesthesia at 37-41 weeks of gestational age will be included in this study.
  • Only patients for primary CD or repeat CD (1x) will be included in this study since excessive uterine scarring from multiple CD may affect the contractility of myometrial sample.

排除标准

  • patient refusal
  • emergency CD
  • general anesthesia
  • placenta accreta spectrum disorder
  • any condition predisposing the patient to uterine atony (e.g. polyhydramnios, multiple gestation)
  • patients taking medications affecting myometrial contractions(labetalol, magnesium etc.).

研究组 & 干预措施

Dexmedetomidine

Active Comparator

The myometrial samples are bathed in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

干预措施: Dexmedetomidine (Drug)

Oxytocin

Active Comparator

The myometrial samples are bathed in oxytocin 20nM.

干预措施: Oxytocin (Drug)

Dexmedetomidine + Oxytocin

Active Comparator

The myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).

干预措施: Oxytocin (Drug)

Dexmedetomidine + Oxytocin

Active Comparator

The myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).

干预措施: Dexmedetomidine (Drug)

Oxytocin pre-treatment followed by Dexmedetomidine

Active Comparator

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

干预措施: Oxytocin (Drug)

Oxytocin pre-treatment followed by Dexmedetomidine

Active Comparator

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

干预措施: Dexmedetomidine (Drug)

Oxytocin pre-treatment followed by Oxytocin

Active Comparator

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM.

干预措施: Oxytocin (Drug)

Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin

Active Comparator

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M)

干预措施: Oxytocin (Drug)

Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin

Active Comparator

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M)

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Motility index

时间窗: 4 hours

Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.

次要结局

  • Amplitude of contraction(4 hours)
  • Frequency of contraction(4 hours)
  • Integrated area under response curve (AUC)(4 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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