Correlation of preoperative anxiety and post spinal hypotension in patients undergoing caesarean section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To study the correlation between preoperative anxiety and hypotension in patients undergoing Caesarean section under spinal anaesthesia.
研究概览
简要总结
This observational prospective longitudinal study will be performed after approval from the institutional ethics committee. All the parturients satisfying the inclusion criteria will be included in our study. Written informed consent will be taken from the patients. Their preoperative anxiety scores will be assessed in the preoperative ward using two standard and validated Scales which measure anxiety:
**1.**Verbal Analogue Scale (VAS) anxiety – Parturients will be asked to rank subjective anxiety on a VAS scale of 0 to 10; where 0 is no anxiety at all and 10 the worst anxiety imaginable. The VAS score obtained will be converted to ordinal data as under:
â€VAS of0 to 3 à Low Anxiety
â€VAS of 4 to 6 à Moderate Anxiety
â€VAS of 7 to 10 à High Anxiety 2.The Amsterdam Preoperative Anxiety and Information Scale **(**APAIS Scale)
| APAIS question Not at all Extremely | |||||
| 1. I am worried about the anaesthetic. 1 2 3 4 5 | |||||
| 2. The anaesthetic is on my mind continually. | |||||
| 3. I would like to know as much as possible about the anaesthetic. | |||||
| 4. I am worried about the procedure. | |||||
| 5. The procedure is on my mind continually. | |||||
| 6. I would like to know as much as possible about the procedure |
The questionnaire consists of two sub scales, both the Anxiety subscale and the Information Need scale. The instrument has 6 questions rated by the patient on a 5-point scale. The Anxiety Subset score (sum C = sum A + sum S) is calculated as the sum of anaesthesia anxiety (sum A =1+2 questions), sum of surgical anxiety (sum S = 4 + 5 questions) and the need for information score is the sum of items 3 and 6. Each statement in APAIS is rated on 5 point scale; 1 not at all; 2 somewhat; 3 moderately so; 4 very much so; 5 extremely. APAIS anxietyscores (sum C) = 4-9 à Low anxiety, 10-14 à Moderate anxiety 15-20 à high anxiety. Base Line Haemodynamic parameters (Heart rate, systolic and diastolic blood pressure) will be noted following this anxiety score assessment. As our institutional practice, following explanation of procedure and written informed valid consent,standard anaesthesia practice is giving spinal anaesthesia in the sitting position using hyperbaric Bupivacaine. On achieving sensory level of T6, surgery is started. Patients with partial or inadequate sensory blockade or achieving sensory levels above T5 will be excluded from the study. In case of any Intraoperative Obstetric complications (like excessive Blood loss, postpartum haemorrhage etc.) the patient will be excluded from the study and the conduct of anaesthesia will follow the standard protocol. However, occurrence of such complications will be noted. Heart rate, Non invasive arterial blood pressure (NIBP) will be measured and recorded at baseline, before administrating spinal anaesthesia and every 2 minute after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes. Time of baby delivery will be noted. Fall in Systolic blood pressure (SBP) by >20 % below baseline will be considered as hypotension and will be treated as per discretion of the involved anaesthesiologist. Requirement of vasopressors and intravenous fluid boluses needed, will be noted. Parameters noted will be – 1.Demographic Data (Age, Height, Weight, Educational Status,Parity) 2.Previous exposure to surgery & anaesthesia 3.Pre-operative Anxiety Score (VAS & APAIs) (Appendix B) 4.Level of Spinal Block (Sensory) 5.Haemodynamic Parameters: Heart Rate, Systolic and Diastolic Blood Pressure, in the supine position at the following events ·On preoperative assessment (Baseline) ·In the operating room - on Table ·Following spinal anaesthesia after patient is made supine ·Every 2 minutes after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes 6. Vasoressors requirement
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •All consenting pregnant patients above age of 18 years, posted for elective and emergency Caeserean section receiving spinal anaesthesia will be included for the study.
排除标准
- •Patients with complicated pregnancy (abruptio placenta/ placenta praevia) 2)Patients having Preeclampsia 3)Patients with preexisting / gestational hypertension 4)Patients with anaemia (Hb<9) 5)Patients with heart, pulmonary, renal or liver disease 6)Patients with psychiatric disorders 7)Inadequate time for anxiety assessment.
结局指标
主要结局
To study the correlation between preoperative anxiety and hypotension in patients undergoing Caesarean section under spinal anaesthesia.
时间窗: Patients will be assessed at the following time intervals: | 1) Baseline assessment | 2) Before spinal anaesthesia | 3) After spinal anaesthesia( 2mins, 4mins, 6mins, 8mins, 10mins, 15mins, 20mins, 25mins, 30mins)
次要结局
- 1. To determine the difference in the need of vasopressors between the different anxiety groups.(2. To determine difference in the level of preoperative anxiety in the patients presenting for elective and emergency Caesarean section)
