Randomized Controlled Trial of Prophylactic Subhypnotic Propofol vs Metoclopramide and in Combination Therapy for the Prevention of Nausea and Vomiting During Subarachnoid Anesthesia for Cesarean Section.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
研究概览
简要总结
Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean section.
Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor trigger zone and is used effectively for the prevention and treatment of nausea and vomiting. Propofol can antagonize Serotonin receptors in the area postremal and is associated to a reduced incidence of postoperative nausea and vomiting. Some studies have shown that propofol can prevent intraoperative nausea and vomiting during cesarean section.
The control of risk factors and the pharmacological prophylaxis of nausea and vomiting reduces effectively their incidence.
In this randomized, double blind, case-control study the efficacy of propofol alone, metoclopramide alone and in combination in controlling nausea and vomiting were compared. A risk factor control strategy was associated to each study group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CESAREAN SECTION WITHOUT MATERNAL OR FETAL SUFFERING
- •American Society of Anesthesiologists score I-II
- •36 TO 41 WEEK OF GESTATION
- •HEMOGLOBIN > 10 mg/dl
- •NO COMPLICATIONS (GESTATIONAL DIABETES, COLESTASIS)
- •NO ACUTE OR CHRONIC GASTROINTESTINAL DISORDERS (GERD excluded)
- •NO SMOKING OR DRUG ABUSE DURING PREGNANCY
- •NO PREVIOUS MAJOR ABDOMINAL SURGERY
- •NO PREVIOUS COMPLICATED PREGNANCIES
- •FETAL WEIGHT > 2.5 kg
排除标准
- •EMERGENCY CESAREAN SECTION WITH MATERNAL OR FETAL SUFFERING
- •American Society of Anesthesiologists score III-IV-V
- •< 36 OR > 41 WEEK OF GESTATION
- •HEMOGLOBIN < 10 mg/dl
- •COMPLICATIONS (GESTATIONAL DIABETES, COLESTASIS)
- •ACUTE OR CHRONIC GASTROINTESTINAL DISORDERS
- •SMOKING OR DRUG ABUSE DURING PREGNANCY
- •PREVIOUS MAJOR ABDOMINAL SURGERY
- •PREVIOUS COMPLICATED PREGNANCIES
- •FETAL WEIGHT < 2.5 kg
研究组 & 干预措施
PROPOFOL
PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION
干预措施: PROPOFOL (Drug)
METOCLOPRAMIDE
METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
干预措施: METOCLOPRAMIDE (Drug)
PROPOFOL & METOCLOPRAMIDE
PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
干预措施: PROPOFOL (Drug)
PROPOFOL & METOCLOPRAMIDE
PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
干预措施: METOCLOPRAMIDE (Drug)
PLACEBO
SALINE INFUSION
干预措施: PLACEBO (Drug)
结局指标
主要结局
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
时间窗: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
INCIDENCE OF NAUSEA AND VOMITING
次要结局
- ADVERSE EVENTS(FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS))
研究者
Zhirajr Mokini
M.D.
Azienda Ospedaliera San Gerardo di Monza