Association Between Pre-Operative Anxiety and Post- Spinal Hypotension in Women Undergoing Elective Caesarean Section: A Cross-Sectional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- To assess the level of preoperative anxiety in patients scheduled for elective Caesarean delivery.
研究概览
简要总结
PRIMARY PURPOSE
1.To assess the level of preoperative anxiety in patients scheduled for elective Caesarean delivery.
2.To identify the association between pre-operative anxiety and blood pressure changes during spinal anaesthesia for elective Caesarean delivery.
STUDY HYPOTHESIS
Hypotension after spinal anaesthesia is primarily due to the suppression of sympathetic outflow. Patients with a higher baseline sympathetic drive were seen to have a profound fall in blood pressure after spinal anaesthesia. Therefore it can be rationalized that patients with higher pre- operative anxiety may have a markedly significant post-spinal hypotension.
PROCEDURE
After obtaining approval from the Department Postgraduate Research Monitoring Committee (PGRMC), Institutional Ethics Committee, this study will be registered in Clinical Trials Registry-India (CTRI). Written informed consent will be obtained from patients after explaining the whole procedure, before the start of the study.
One day before or on the day of surgery, the pre-operative anxiety of the patient is assessed using four standard direct psychological measures of anxiety:
1) State-Trait Anxiety Inventory (STAI)
2) Visual Analogue Scale For Anxiety Mood (VAS)
Indirect physical measure of anxiety using Salivary Amylase will also be done. Salivary sample will be collected using a hand-held monitor called Cocorometer from Nipro, Osaka, Japan. This device has a main monitor and test-strips which are sufficient to collect saliva. Saliva will be collected from the sublingual area in about 30 seconds using the test-strips.
The baseline blood pressure will be recorded on arrival of the patient to the operating theatre. A 18G/20G intravenous line is secured and 500 ml of Ringer’s Lactate is given as pre-load/co load before the administration of spinal anaesthesia. Spinal anaesthesia will be administered in the left lateral position, at the level of L4–L5 or L5–S1 intervertebral space using 1.8 to 2ml (depending on the height of the patient) of 0.5% hyperbaric bupivacaine. After administration the patient is immediately placed in supine position with a wedge under the right hip. Surgery will be allowed to begin when the sensory level of block is at least T4 level bilaterally.Maternal blood pressure will be measured during the intra-operative period using Non-invasive Blood Pressure (NIBP) monitor. All measurements will be made in the supine position with left uterine displacement using wedge at right hip. Blood pressure will be measured at baseline, immediately before spinal anaesthesia, and every minute after spinal anaesthesia until delivery and every 5 mins until completion of surgery.
Systolic Blood Pressure (SBP) below 100 mm Hg will be treated with a fluid bolus of 250–500 ml. SBP below 90 mm Hg will be treated with I.V. vasopressors (mephentermine/phenylephrine) depending on maternal heart rate.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •All consenting parturients admitted at JIPMER for elective Caesarean section under spinal anaesthesia with American Society of Anaesthesiologist (ASA) status II and III.
排除标准
- •Uncontrolled systemic hypertension
- •Preeclampsia
- •Preexisting hypotension
- •Known case of psychiatric disorder on regular medication
- •Any contraindication for spinal anaesthesia
- •H/o alcoholism
- •Infection of salivary glands
- •K/c/o acute or chronic pancreatitis.
结局指标
主要结局
To assess the level of preoperative anxiety in patients scheduled for elective Caesarean delivery.
时间窗: Preoperative period | that is one day before surgery or on the day of surgery
次要结局
- To identify the association between pre-operative anxiety & blood pressure changes during spinal anaesthesia for elective Caesarean delivery.(Intra-operative period)
研究者
Dr Manoj Kumar J
Jawaharlal Institute of Postgraduate Medical Education & Research
