A Prospective Randomised Double Blind interventional Comparative study of administration of Ondansetron 8mg intravenous versus placebo before Spinal Anaesthesia in attenuation of post Spinal Hypotention at SMS Medical College, Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- 1.To determine the difference in fall of systolic blood pressure SBP (in mm Hg), diastolic pressure (DBP in mm Hg), mean arterial pressure(MAP) and heart rate (HR) between both groups.
研究概览
简要总结
Hypotension is seen in as many as 50% of the parturients undergoing lower segment caesarean section (LSCS) under spinal anaesthesia. Hypotension due to spinal anaesthesia is mainly caused by sympathetic blockade . In obstetric patients spinal anaesthesia induced hypotension is further aggravated due to aortocaval compression by gravid uterus. Many techniques such as lower legs compression, uterine displacement, using vasopressor and administering fluids has shown a decrease in incidence of hypotension.
In this study, we plan to study and compare the effect of 8mg intravenous (IV) ondansetron and placebo given prophylactically 5 minutes (min.) before spinal anaesthesia on incidence of hypotension in patients undergoing elective caesarean section.
For this study a total of 174 patients (n=174) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 87 each (n=87) (A and B),Group A will receive 8mg of IV ondansetron and group B will receive placebo 5min. before spinal anaesthesia .
When patient arrives in the operating room (OR), IV cannula will be inserted and haemodynamic variables will be measured. After this patient will receive 4mg of IV ondansetron (Group A) and 8mg of IV ondansetron 5min. before spinal anaesthesia. After this spinal anaesthesia will be administered. Patient will be put in supine position immediately. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of ephedrine use (mg) and IV crystalloids (L) will be recorded.
Haemodynamic parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), pulse rate (PR), oxygen saturation (SPO2), and respiratory rate (RR) will be recorded preoperatively and intraoperatively. The data will be collected in a prescribed proforma and statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient consenting to participate.
- •2.Adult patients 3.Patient belonging to ASA grade II.
排除标准
- •1.Patients with contraindication to neuraxial anaesthesia.
- •2.Patient with history of drug abuse or addictions.
- •3.SA converted to general anaesthesia.
- •4.Allergy to ondansetron or local anaesthetic contraindication to regional anaesthesia and on medications which acts on the 5HT3 receptors were excluded from the study.
结局指标
主要结局
1.To determine the difference in fall of systolic blood pressure SBP (in mm Hg), diastolic pressure (DBP in mm Hg), mean arterial pressure(MAP) and heart rate (HR) between both groups.
时间窗: PRE OP | 00 (after spinal) | 01 min | 02 min | 03 min | 05 min | 10 min | 15 min | 20 min | 25 min | 30 min | 40 min | 50 min | 60 min
2.To determine difference in dose of ephedrine requirement in (mg) in both groups
时间窗: PRE OP | 00 (after spinal) | 01 min | 02 min | 03 min | 05 min | 10 min | 15 min | 20 min | 25 min | 30 min | 40 min | 50 min | 60 min
次要结局
- 1.To observe side effects – if any(PRE OP)
研究者
Dr Harpreet Kaur
Sawai Man Singh Medical College and Attached Hospitals