Does Smoking Effect Spinal Anesthesia in Parturient Women? A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS scores
研究概览
简要总结
Background In the last 10 years, the rate of smoking in women of childbearing age has increased gradually. The smoking affects general anesthesia negatively. Can smoking also affect regional anesthesia in pregnant women? Our aim in this study is to investigate the effects of smoking on spinal anesthesia applied for C/S in pregnant women.
Methods After approval of the institution's ethics committee, 100 patients will divided in two groups as pregnant women who did not smoke during pregnancy and pregnant women who smoked 5 or more cigarettes in a day. The local anesthetic, which dose will be adjusted according to height and weight, and 20 µg fentanyl will administered intrathecally to both groups. Results on the effectiveness of spinal anesthesia will monitored.
Results The data of 100 parturients will investigated. The onset time of sensory and motor block, the duration of motor and sensory block, APGAR and VAS scores will be monitored. In addition, C/S indications, side effects, patient satisfaction, additional medication need and, spinal anesthesia preferences will be monitored.
Conclusions Smoking affects many systems. According to the onset of sensory block, duration of sensory and motor block and, VAS scores, which determine the effectiveness of spinal anesthesia, it will be evaluated whether smoking also affects spinal anesthesia in pregnant women.
详细描述
MATERIALS AND METHODS
Ethical approval:
This prospective, randomized-controlled, observational study was conducted at Van Research and Training Hospital with a bed capacity of 1500 located in Van, Turkey. Approval was obtained from the institution's ethics committee (2019/18), and the study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.
Groups and Randomization: The patients included in the study will be divided into two groups. Pregnant women who did not smoke during pregnancy (Group NS, Non-Smoker) (n=50) and pregnant women who smoked 5 or more cigarettes per day (Group S, Smoker) (n=50) will be randomly included in the study.
Procedure: 8-10 mL/kg of crystalloid fluid intravenous hydration will be administered for 10-15 minutes to each patient taken to the operating table. Electrocardiography (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) monitoring will be routinely performed. NIBP values, heart rate (HR), and SpO2 values will be recorded before the procedure (T0).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients with an American Society of Anesthesiologists (ASA) status of class I-II,
- •Aged between 18 and 45 years,
- •Scheduled to undergo spinal anesthesia for elective C/S
排除标准
- •The requirement of emergency C/S for delivery,
- •ASA class ≥ III patients,
- •A contraindication for spinal anesthesia,
- •Multiple gestations,
- •Placental abnormalities
- •Allergy to local anesthetics,
- •Height shorter than 150 cm,
- •Coagulation disorders and
- •Refusal of spinal anesthesia.
结局指标
主要结局
VAS scores
时间窗: Pain level will be checked with VAS score at 4-hour intervals up to 24 hours.
Patients will be informed about the Visual Analogue Scale, which will be used to evaluate the pain they felt preoperatively, intraoperatively and postoperatively (0; No pain - 10; extreme pain).
Duration of sensory block,
时间窗: The duration of sensory block will be controlled until it regresses to the L1 level, up to 6 hour.
After intrathecal drug administration, sensory block levels will be checked with cold-hot tes at 2-minute intervals in the first 10 minutes. The cold-hot test will be repeated every 15 minutes during and after surgery until the the sensory block regressed to the level of the L1 dermatome. Overall duration of sensory block was defined as the start of the sensory block to the time when the sensory block regresses to L-1 dermatome level.
Duration of motor block,
时间窗: The motor block will be followed until Bromage scales regress to zero point, up to 6 hour.
Motor block levels will be checked with the Bromage Scale every minute for the first 10 minutes after intrathecal drug administration. Overall duration of motor block was defined as the start of the motor block to the time when the motor block regresses to 0 level according to the Bromage scale.The motor block test will be repeated every 15 minutes during and after surgery until the Bromage Scale regresses to 0 point.
Sensory block onset,
时间窗: The sensory block onset will assessed 3 min after administering the spinal anesthetic, up to 10 minute.
After intrathecal drug administration, sensory block levels will be checked with cold-hot test per one-minute intervals in the first 10 minutes. Time taken for sensory block to reach T6 dermatome will be recorded.
次要结局
未报告次要终点
研究者
Hacı Yusuf Güneş
Assistant proffesor
Yuzuncu Yıl University