The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
试验速览
- 阶段
- 1 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- preoperative maternal anxiety changes
研究概览
简要总结
There is exaggerated neuroendocrine stress response to laryngoscopy and endotracheal intubation during the Induction to anesthesia-delivery (I-D) period under light anesthesia. Mechanical stimulation of laryngeal proprioceptors elicits increased secretion of cortisol and catecholamine with subsequent elevation of blood pressure from 40 to 50 % and heart rate up to 20 % during direct laryngoscopy and endotracheal intubation
详细描述
The sample size was calculated using OPEN EPI program assuming that the mean visual analogue scale anxiety score was 49.3±14.1 among oral pregabalin group and was 58.6± 14.4 among Placebo group (8) so at power of study 80% confidence interval 95%, the sample size was calculated to be 74 cases (37in each group
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 21-38 years old.
- •Pregnant Female with a singleton fetus of at least 36 weeks of gestation.
- •American Society of Anesthesiologist Physical status: 1& II.
- •Body Mass Index (BMI) (25-30kg/m²).
- •Type of operations: elective caesarean section under general anesthesia.
- •Written informed consent from the parturient.
排除标准
- •Altered mental state.
- •Women with known history of allergy to pregabalin.
- •Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, Hepatic, renal, Cardiovascular, respiratory disease and neuropsychiatric disorders.
- •Patients receiving anticonvulsants, antidepressants.
- •Pregnancy induced hypertension, intrauterine growth restriction or fetal compromise
研究组 & 干预措施
pregabalin
oral capsule pregabalin 150 mg.
干预措施: Pregabalin 150mg (Drug)
multivitamin
oral multivitamin capsule.
干预措施: multivitamin (Drug)
结局指标
主要结局
preoperative maternal anxiety changes
时间窗: change from baseline at 60 minutes after giving drug preoperative.
Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).
次要结局
- Number of participant with changes in level of consciousness(at 60 minutes preoperative)
- mean arterial blood pressure(at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.)
- Heart rate(at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.)
- cortisol level(preoperative and at 10 minutes after intubation.)
- Baby Apgar score(at 1 and 5 minutes after delivery)
- Serum glucose(preoperative and at 10 minutes after intubation.)
研究者
Sara mohamed Abdelnaby
lecturer of anaesthesia and surgical intensive care
Zagazig University