Efficacy of preoperative intravenous and nebulized lignocaine for attenuation of pressor response to laryngoscopy and intubation in severe preeclampsia undergoing lower segment cesarian section a randomized double blind study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Difference in Systolic blood pressure
研究概览
简要总结
This is randomized double blind study comparing efficacy of nebulized versus intravenous lignocaine for attenuation of pressor response during laryngoscopy and intubation on patients with severe preeclampsia undergoing LSCS under general anaesthesia. Patients will be enrolled with sample size of 80 (40 in each group) after clinical evaluation and informed consent. Participants will be randomly divided into two groups by computer-generated numbers to receive either nebulized lignocaine or intravenous lignocaine as premedication.
Standard monitoring and anaesthesia protocols will be followed, including induction under general anaesthesia and maintenance with isoflurane, nitrous oxide, and oxygen. As primary outcome vitals will be monitored during the preoperative period, before induction, after laryngoscopy and intubation, and every 30 seconds until 5 minutes and secondary outcome will be Neonatal Apgar scores recorded at 1 and 5 minutes after the baby is delivered Cough score using a 4-point scale, hoarseness of voice and sore throat at 1 and 2 hours postoperatively using standardized grading systems, and patients will be observed in the PACU for 24 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients with severe preeclampsia (Systolic blood pressure more than 160 mmhg or diastolic blood pressure more than 110 mmhg at two occasions at least 4 hour apart, new onset headache or visual disturbance, platelet less than1 lakh, epigastric pain) undergoing Lower Segment cesarian section
- •Mallampatti grading I and II.
排除标准
- •More than one attempt of intubation
- •Time taken for intubation more than 40 seconds
- •Any cardiac diseases, uncontrolled diabetes mellitus 4.
结局指标
主要结局
1.Difference in Systolic blood pressure
时间窗: Baseline (Before nebulization) T0 | Before iv injection (T1) | Before induction (T2) | After induction & before laryngoscopy (T3) | After laryngoscopy & before intubation(T4) | After intubation (T5) | 1MIN (T6) | 1 MIN 30 SEC (T7) | 2MIN (T8) | 2 MIN 30 SEC (T9) | 3 MIN (T10) | 3MIN 30 SEC (T11) | 4MIN (T12) | 4MIN 30 SEC (T13) | 5MIN
2.Difference in Diastolic blood pressure
时间窗: Baseline (Before nebulization) T0 | Before iv injection (T1) | Before induction (T2) | After induction & before laryngoscopy (T3) | After laryngoscopy & before intubation(T4) | After intubation (T5) | 1MIN (T6) | 1 MIN 30 SEC (T7) | 2MIN (T8) | 2 MIN 30 SEC (T9) | 3 MIN (T10) | 3MIN 30 SEC (T11) | 4MIN (T12) | 4MIN 30 SEC (T13) | 5MIN
3.Difference in mean arterial pressure
时间窗: Baseline (Before nebulization) T0 | Before iv injection (T1) | Before induction (T2) | After induction & before laryngoscopy (T3) | After laryngoscopy & before intubation(T4) | After intubation (T5) | 1MIN (T6) | 1 MIN 30 SEC (T7) | 2MIN (T8) | 2 MIN 30 SEC (T9) | 3 MIN (T10) | 3MIN 30 SEC (T11) | 4MIN (T12) | 4MIN 30 SEC (T13) | 5MIN
4.Difference in heart rate
时间窗: Baseline (Before nebulization) T0 | Before iv injection (T1) | Before induction (T2) | After induction & before laryngoscopy (T3) | After laryngoscopy & before intubation(T4) | After intubation (T5) | 1MIN (T6) | 1 MIN 30 SEC (T7) | 2MIN (T8) | 2 MIN 30 SEC (T9) | 3 MIN (T10) | 3MIN 30 SEC (T11) | 4MIN (T12) | 4MIN 30 SEC (T13) | 5MIN
次要结局
- 1.Incidence and grade of coughing during extubation(2.Incidence and grade of hoarseness)
研究者
Dr Rajendra Jhariya
Pt J N M Medical college Raipur