Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Number of Patients With Vomiting
研究概览
简要总结
The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.
详细描述
Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma.
To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics.
In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects ages 18 to 45
- •Subjects with ASA Class I or II
- •Subjects with elective primary or repeat cesarean delivery
- •Subjects who receive spinal and/or epidural anesthesia
- •English and non-English speaking subjects will be included in the study
排除标准
- •Female subjects <18 years of age
- •Subjects requiring emergent cesarean delivery
- •Gestational age < 37 weeks
- •History of placenta accreta
- •Multiple gestation pregnancy
- •ASA status III or higher
- •Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
- •History of any chronic medication use (other than prenatal vitamins), including inhaler medications
- •Current urinary tract infection, pneumonia, or otitis media
- •Coagulopathies or skin infections overlying the spine
- •History of open angle glaucoma, seizures or psychosis
研究组 & 干预措施
scopolamine patch
Scopolamine patch will be placed on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery.
干预措施: scopolamine patch (Drug)
acupressure point P6
Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist.
干预措施: acupressure point P6 (Device)
scopolamine patch + acupressure point P6
Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
干预措施: scopolamine patch (Drug)
scopolamine patch + acupressure point P6
Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
干预措施: acupressure point P6 (Device)
结局指标
主要结局
Number of Patients With Vomiting
时间窗: Throughout the surgical procedure
The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Number of Patients With Nausea
时间窗: Throughout the entire surgical procedure
The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.
次要结局
- Level of Nausea After the Administration of the Regional Anesthesia Medications(From administration of anaesthesia until eversion of uterus)
- Satisfaction With Intraoperative Antiemetic Treatment(Throughout the surgical procedure)
- Level of Nausea After Eversion of the Uterus(After eversion of the uterus until replacement of the uterus)
- Level of Nausea After Replacement of the Uterus(After replacement of the uterus and to the next 15 minutes)
- Level of Nausea Upon Arrival to the Post-operative Recovery Room(15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit)
- Number of Patients With Vomiting After Eversion of the Uterus(After eversion of to replacement of the uterus)
- Number of Patients With Vomiting After Replacement of the Uterus(After replacement of the uterus and for next 15 minutes)
- Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications(After the administration of the regional anesthesia medications until eversion of the uterus)
- Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room(From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit)
研究者
Shaul Cohen, M.D.
Director of Obstetric Anesthesia
Rutgers, The State University of New Jersey