Effect of Sevoflurane on the Success of External Cephalic Version for Breech Presentation
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- The success rate of ECV under sevoflurane compared with that without sevoflurane in parturient undergoing elective ECV at 36-40 weeks of gestation.
研究概览
简要总结
External cephalic version (ECV) is noninvasive procedure aiming to turn the fetus to cephalic presentation, thereby enabling vaginal delivery and avoiding unnecessary cesarean delivery. The American College of Obstetricians and Gynecologists (ACOG) suggested that all women near term with breech presentation should be offered a version (9). Its success rate depends on the experience of obstetrician in addition to maternal factors. Several interventions have been tried to increase the success rate of ECV, including but not limited to tocolytics and neuraxial anesthesia. Although parenteral β stimulants and spinal anesthesia proved to be effective for increasing the success rate ECV, their success rates are still not high (10, 11) Sevoflurane's pleasant odor, lack of pungency, and potent bronchodilating characteristics make sevoflurane administration via the facemask for either sedation or induction of anesthesia is suitable. Sevoflurane has sedative and uterine relaxation effects all together would facilitate ECV and consequently would increase its success rate. To the best our knowledge sevoflurane has never been studied for ECV. Up to 1% concentration of sevoflurane has been used for labor analgesia without excessive sedation (8). Therefore, the investigators aim at comparing the success rate of ECV at 36-40 weeks of gestation under 1% of sevoflurane with a control group (received no anesthetic or other obstetric interventions). Other outcomes such as pain score and maternal and fetal complications will also be evaluated.
详细描述
Pre- procedure all parturients will be asked to be fasting for 8 hours for solid and 2 hours for clear liquids. Before ECV (as routinely done in ECV procedure), a cardiotocogram (CTG) and obstetric ultrasound will be done to confirm the fetal wellbeing and fetal position prior to procedure. The mother and fetus were monitored for at least 30 min before attempting ECV. The procedure will be performed by one of two experienced obstetricians. Fetal heart rate will be recorded throughout the procedure.
In the operating room, standard monitoring will be placed, as well as intravenous line will be established on an upper limb. Baseline measures of BP, HR, O2 Saturation will be taken before proceeding to inhalation sedation, including 3 baseline blood pressure readings to determine baseline values. A circle system, including antibacterial filter and scavenging system is connected to the anesthesia machine (Datex-Ohmeda).
If the parturient is assigned to the control (nonintervention) group, the participants will not receive any medications neither tocolytics nor analgesics as we do routinely in our hospital. However, these participants will be monitored throughout the procedure for vital signs and for pains scores as in the intervention group (see below).
In the intervention group, each participant started by preoxygenation of 100% oxygen for 3minutes. Then, parturients breath 1% of sevoflurane in mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min. Values of inspired (FI) and end-tidal (FET) concentrations of sevoflurane, oxygen and respiratory rate (RR) measured by end-tidal carbon dioxide (EtC02) were monitored continuously and recorded at 30 seconds intervals by a gas analyzer.
Thirty seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure. HR, FI and FET concentration of sevoflurane, Sp02 and EtC02 will be recorded at 30 seconds intervals during ECV. Non-invasive BP will be recorded every one minute. The duration of ECV in addition to the level of difficulty estimated by obstetrician will be recorded. In noninterventional (control) group, the patients will not receive any medication or anesthetic intervention however their vital signs including Sp02, BP and HR will be monitored throughout the procedure at the same interval used for the intervention group, their pain score will be measured as in the intervention group (see below).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old
- •ASA status I or II (healthy women or patient with mild well-controlled systemic disease)
- •Elective ECV
- •36 to 40 weeks of gestation
排除标准
- •Multifetal gestation
- •Morbid obesity (BMI > 40 at first prenatal medical visit)
- •Oligohydramnios or polyhydramnios (AFI <5 cm or > 23 cm)
- •Fetal weight >4200g
- •Active labor
- •Uterine tumors or anomalies
- •Abnormal placentation such as Placenta accreta/Previa
- •Placental abruption
- •Intrauterine fetal death
- •Known allergy to sevoflurane
- •History of malignant hyperthermia
- •Administration of any tocolytics before or during ECV
研究组 & 干预措施
Sevoflurane
Each participant started by preoxygenation of 100% oxygen for 3 minutes. Then, parturients breath 1% of sevoflurane in mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min. Values of inspired (FI) and end-tidal (FET) concentrations of sevoflurane, oxygen and respiratory rate (RR) measured by end-tidal carbon dioxide (EtC02) were monitored continuously and recorded at 30 seconds intervals by a gas analyzer.
30 seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure. HR, FI and FET concentration of sevoflurane, Sp02 and EtC02 will be recorded at 30-s interval during ECV. Non-invasive BP will be recorded every one minute. Duration of ECV in addition to level of difficulty estimated by obstetrician will be recorded.
ECV considered successful when a cephalic presentation, confirmed by ultrasound scan, achieved.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
The success rate of ECV under sevoflurane compared with that without sevoflurane in parturient undergoing elective ECV at 36-40 weeks of gestation.
时间窗: 20 minutes
ECV considered successful when a cephalic presentation assessed by direct palpation of maternal abdominal wall by obstetrician and confirmed by ultrasound scan is achieved.
次要结局
- The pain score (by using visual analogue scale) during ECV under sevoflurane versus that during ECV without sevoflurane(20 minutes)
- The maternal satisfaction during ECV procedure between sevoflurane group versus control group(20 minutes)
- The duration of ECV under sevoflurane versus without sevoflurane(10 minutes)
- The incidence rate of complications related to ECV between sevoflurane group versus control group(45 minutes)
- The incidence of adverse effects after administration of sevoflurane for ECV with that of control group.(45 minutes)
- The mode of delivery (vaginal or cesarean) after successful ECV between sevoflurane versus control group(2 months)
研究者
Adel Alqarni
Assistant professor and consultant of anesthesia
King Saud University