A Comparative Study of Supine Position and the Head Elevated Position on the Level of Sensory Block After Spinal Anesthesia in Morbidly Obese Parturient Undergoing Elective Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The sensory level (loss of cold and pin prick sensation) at 15 min after the intrathecal administration of the medication in the parturient
研究概览
简要总结
The sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical,Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)has been shown to not only increase respiratory reserve but also to improve laryngeal views in patients undergoing bariatric surgery. Additionally it helps in pre-oxygenating the patient more efficiently by keeping the airway patent and provides easier bag-mask ventilation.
It may also benefit the term parturient in a similar way by improving functional residual capacity (FRC), ventilation and comfort. However, this positon may affect the cephalad spread of the intrathecal local anesthetic.
Two earlier studies looked at the intrathecal local anesthetic spread in obstetric patients when placed in the head elevated laryngoscopy position, and both suggested poor cephalad spread, with patients requiring higher supplementation.
However, both studies excluded morbidly obese patients. The Investigators hypothesized that in obese parturients with BMI more than or equal 40, higher intra-abdominal pressures and possibly lower CSF volumes will counteract the poor cephalad spread associated with this position. The aim of this study is to determine the effect of a ramped position on intrathecal local anesthetic spread in the morbidly obese term parturients with BMI more than or equal 40 undergoing elective Cesarean delivery(CD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age 18yrs of age or more
- •BMI 40 or more and more than or equal 37 weeks of gestation
- •elective CD
- •consented for neuraxial anesthesia
- •singleton fetus
- •ASA class 3 (no co-morbidities except morbid obesity, gestational diabetes, and gestational hypothyroidism)
排除标准
- •Age <18 years
- •BMI less than 39.9 and <37 weeks of gestation
- •parturient preference for general anesthesia or contraindication to neuraxial anesthesia
- •Women with comorbidities other than obesity, gestational diabetes or gestational hypothyroidism.
- •women in active labor (>3 cm dilated with regular uterine contractions)
- •emergency CD
- •Possible uterine over-distension or under-distension (e.g. polyhydramnios, estimated fetal weight >4 kg by ultrasound scan, or oligohydramnios or concern for fetal IUGR)
- •maternal height <150 cm or >180 cm.
- •Patients for which more than 2 minutes is taken in positioning after anesthesia induction (Time 0).
研究组 & 干预措施
HEAD ELEVATING LARYNGOSCOPY PILLOW
the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical, Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)
干预措施: head elevated laryngoscopy position by Oxford pillow (Other)
Standard pillow group
Standard pillow group
结局指标
主要结局
The sensory level (loss of cold and pin prick sensation) at 15 min after the intrathecal administration of the medication in the parturient
时间窗: From date of randomization until the date of first documented progression, assessed up to 48 months
次要结局
- Incidence of inadequate block level at 15 min and need for epidural supplements(From date of randomization until the date of first documented progression, assessed up to 48 months)