Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension in Preoperatively Anxious Parturients Undergoing Urgent Category-1 Cesarean Section: A Historical Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Maximum systolic arterial pressure (SAP) reductions from the baseline values
研究概览
简要总结
Background: This study was designed to investigate the effect of sedation on the occurrence of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia.
Methods: After institutional ethics committee approval, prospectively collected data of 1824 parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in the analysis. Hemodynamic parameters were documented and maximum systolic arterial pressure (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of hypotension (SAP≥30% decrease from baseline or <100 mmHg) and bradycardia (HR<55 beats/min), and related-ephedrine and -atropine requirements were noted. Our primary endpoint was to compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine doses, newborn Apgar scores at 1st and 5th min.
详细描述
Background: This study was designed to investigate the effect of thiopental sodium sedation on the occurrence of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia.
Methods: After institutional ethics committee approval, prospectively collected data of 1824 parturients undergoing C/S at Van Training and Research Hospital between August 2014 and February 2015 were reviewed. Parturients with high preoperative anxiety scores (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in the analysis. All parturients received SA with hyperbaric bupivacaine 0.5% 2.5 mL. Hemodynamic parameters were documented and maximum systolic arterial pressure (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of hypotension (SAP≥30% decrease from baseline or <100 mmHg) and bradycardia (HR<55 beats/min), and related-ephedrine and -atropine requirements were noted. All data were obtained from the surgical database and patient charts. Primary endpoint of our study was to compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine doses, newborn Apgar scores at 1st and 5th min.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Urgent category-1 C/S
- •ASA physical status I-II
- •Aged between 18 and 35 years
- •Term (≥37 weeks) singleton pregnancy
- •BMI <40 kg/m2
- •Height >150 cm or <180 cm
- •High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) ≥70)
- •Spinal anesthesia with thiopental sodium sedation
- •Spinal anesthesia without any sedation
排除标准
- •Preoperative prehydration
- •Placenta previa
- •Placenta accreta
- •Hypertension
- •Pregnancy-induced hypertension
- •Urgent category ≥2
- •General anesthesia
- •Spinal anesthesia with sedation other than thiopental sodium
研究组 & 干预措施
Sedation (S)
Parturients who received IV thiopental 2 mg kg-1 and if necessary additional 50 mg immediately after spinal anesthesia until reaching at least Ramsay sedation score of 3 (1: patient anxious, agitated or restless, 6: patient with no response to light glabella tap or loud auditory stimulus.).
干预措施: Sedation (Drug)
No sedation (NS)
Parturients who did not receive any sedative agent after the spinal anesthesia performance.
干预措施: No sedation (Drug)
结局指标
主要结局
Maximum systolic arterial pressure (SAP) reductions from the baseline values
时间窗: 0-10 minutes
% SAP reduction after spinal anesthesia
次要结局
- Newborn Apgar score 1st min(1st min)
- Incidence of maternal hypotension(0-30 minutes)
- Incidence of maternal bradycardia(0-30 minutes)
- Ephedrine requirement(0-30 minutes)
- Incidence of maternal nausea(0-30 minutes)
- Incidence of maternal vomiting(0-30 minutes)
- Atropine requirement(0-30 minutes)
- Newborn Apgar score 5th min(5th min)
研究者
Dr.Cenk Sahan
Attending Anesthesiologist
Van Training and Research Hospital