Effect of pre-operative 0.5% Ropivacaine nebulization on extubation response in patients undergoing general anaesthesia - A Double blinded randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the incidence and severity of cough between preoperative 0.5% Ropivacaine nebulization versus 0.9% normal saline nebulization in patients undergoing general anaesthesia with endotracheal intubation.
研究概览
简要总结
This is a prospective randomised controlled trial to be con ducted on patients aged 18-60 years belonging to ASA I and II posted for elective surgeries under general anaesthesia. After obtaining Institute’s Ethics Committee clearance and informed written consent, the patients will be randomly allocated to one of the three study groups. All the patients will be kept fasting overnight and will be premedicated with oral lorazepam 1mg on the day before the surgery, oral pantoprazole 40mg and oral metochlopromide 10mg will be given on the day before and also on the morning of surgery. Patients will be shifted to the pre operative holding area 30 minutes before the scheduled surgery and baseline vital parameters will be checked. An 18G IV cannula will be secured over the non operative side hand and maintenance IV fluids will be started at a rate of 10ml/kg/hr. After opening the envelope the drug will be prepared as a uniform 5ml solution, the anaesthesiologist who is not a part of the study. The primary anaesthesiologist blinded to the assignments will administer nebulisation to patients in all groups and will be recording all the study parameters. Drug will be administered as aerosol through nebulisation. Nebulisation will be done with a nebulizer by an insufflation gas (100% oxygen at a flow rate of 10 l/min from a wall mount oxygen port through a 200cm tubing connected from the oxygen port to the face mask attached with a nebuliser. Patient will be propped up and advised to take normal tidal volume breaths. Nebulisation will be continue until the complete solution in the nebulizer got areosolized(10-15 min). Ten minutes after completion of nebulisation, patients will be preoxygenated with 100% oxygen for 5 min and then induced with injection midazolam 30 mcg/kg, fentanyl 2 ug/kg, propofol 2mg/kg, and vecuronium 0.1mg/kg. After 3 min of assisted ventilation, patients will be intubated with the appropriate size endotracheal tube. Anaesthesia will be maintained with O2;N2O; mixture in the ratio of 1:1 and isoflurane at 0.8 to 1 MAC.. Tidal volume was controlled at 7ml/kg, the respiratory rate will be set at 12/min, and the inspiratory/expiratory ratio will be set at 1:2, the cuff pressure will be maintained at 20cm of H2O by hand held cuff pressure manometer. Supplementary analgesia will be provided by injection paracetamol at a dose of 15mg/kg. At the end of the case, orophranyx suctioned, inhalational agent will be stopped and patient will be administered 100% oxygen.After return of spontaneous respiration, neuromuscular blockade will be reversed with of 0.05 mg/kg neostigmine and 0.01 mg/kg of injection glycopyrolate. Trachea will be extubated when patient demonstrated the ability to follow verbal commands or showed purposeful movements in addition to resumption of regular spontaneous respiration.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients between age groups 18 to 65 years and belonging to American society of Anesthesiologist physical status classification ASA-PS-I &II.
- •Patient scheduled for elective general anaesthesia procedures.
排除标准
- •allergic to local anaesthetics.
结局指标
主要结局
To compare the incidence and severity of cough between preoperative 0.5% Ropivacaine nebulization versus 0.9% normal saline nebulization in patients undergoing general anaesthesia with endotracheal intubation.
时间窗: Heart rate, Mean arterial pressure, spo2 will be recorded at baseline, upon tracheal intubation, every 1 minute till 5 minutes, Every 5 minutes after intubation till 20 mins, upon anaesthetic withdrawal, upon eye opening on verbal commands, upon tracheal extubation, immediately after extubation, every 5 minutes after extubation till 20 minutes. | Incidence and severity of cough by Modified 4 point Minogue scale.
次要结局
- To compare perioperative hemodynamics, time to extubation, incidence and severity of sore throat(Hemodynamics will be recorded at baseline,upon tracheal intubation,every 1 minute till 5 minutes,Every 5 minutes after intubation till 20 mins, upon anaesthetic withdrawal,upon eye opening on verbal commands, upon tracheal extubation every 5 minutes after extubation till 20 minutes.)
研究者
MAHALAKSHMI
Pondicherry Institute of Medical Sciences
