The effect of different dilution methods of intrathecal morphine on post operative nausea, vomiting and pruritus in patients undergoing elective casearean section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the effect of intrathecal morphine on pruritus and post operative nausea,vomiting.
研究概览
简要总结
Parturients planned to undergo elective cesarean section will be evaluated
Patients will be selected based on inclusion criteria
Informed and written consent will be taken from the study participants
On the day of surgery patients are shifted to the operation tteatre and monitors are connected
Spinal anaesthesia is given with inj.bupivacaine 0.5%(Heavy) of dose 10 mg along with morphine 0.1mg .
GROUP A : WILL BE RECEVING : One gradation of 10 mg/ml of morphine that is taken in 5cc syringe[1mg of morphine] and diluted with 0.9% of Normal saline to make it 5ml so that each ml contains 200mcg , and half ml will have 100mcg.[ one step method]
GROUP - B : WILL BE RECEVING: One ml of 10mg/ml of morphine that is taken in 10cc syringe [10mg of morphine] and diluted with 9ml of 0.9% Normal saline to make it 10ml so that each ml contains 1mg , and one ml of this solution is taken in 5cc syringe and diluted further with 4ml of 0.9% of Normal saline , so that each ml contains 200mcg and half ml will have 100mcg.[two step method].
GROUP - C : WILL BE RECEVING: One ml of morphine [10mg/ml] that is taken in insulin syringe [1ml =40 units] , so that 1 unit will contain 250 mcg of morphine . This 2 units of morphine is taken in 3cc syringe and diluted with 2.5ml of 0.9% of Normal saline , so the final solution w ill have 200 mcg/ml and half ml will contain 100mcg.[ insulin syringe method].
Assessment of hemodynamics, motor block and sensory block
Intraoperative monitoring of HR, BP, SpO2, ECG at intervals of every minute for the first 5 min and every 3 min for rest of the surgery.
Patient will be shifted to PACU and monitored for post-operative nausea,vomiting and pruritus for every hour for first 4 hours and every 4 hrs for the next 24 hrs .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adults of ASA physical status II aged 18 to 45 years with gestational age between 37-42 weeks planned for elective cesarean section.
- •Parturients of height 150cm-170cm.
排除标准
- •1] Multiple pregnancy 2] Patients with known history of pregnancy induced hypertension and gestational diabetes mellitus 3] Any contraindications to spinal anaesthesia 4] Patients with known allergy to bupivacaine and morphine.
结局指标
主要结局
To assess the effect of intrathecal morphine on pruritus and post operative nausea,vomiting.
时间窗: 1] post operative nausea,vomiting is recorded hourly for the first four hours and then fourth hourly for the next twenty four hours using three point ordinal scale. | 2] Pruritus will be recorded every four hours for twenty four hours after surgery on a four point categorical scale.
次要结局
- 1] To assess the postoperative pain(2] To assess for other opiod side effects)
研究者
V B S HRULLEKHA
Jss medical college and hospital