Comparison of intra-cuff ropivacaine versus intratracheal ropivacaine on the hemodynamic response to endotracheal tube during emergence from general anesthesia: A randomized controlled trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- HR,BP will be rising during the time of extubation, which will be blunted in this study. Post operative sore throat and cough will not be there.
研究概览
简要总结
After shifting the patient inside the operative room, standard ASA monitors will be attached and baseline parameters of heart rate (HR), noninvasive blood pressure (NIBP), continuous electrocardiogram (ECG) and arterial oxygen saturation (SpO2) will be noted. An intravenous line secured with an 18 G cannula, and all patients will be received ringer lactate infusion at a rate of 10 ml/kg/hr. As per the institutional protocol general anaesthesia induction will be proceeded. All patients will be premedicated with injection IV glycopyrrolate 0.005mg/kg mg and midazolam 0.05 mg/kg Anesthesia will be induced in the supine position with the head on a standard pillow of 7 cm in height. After preoxygenation for three minutes, anesthesia will be induced using propofol 2mg/kg. After checking for the ability to achieve adequate mask ventilation, succinylcholine 2mg/kg will be used to facilitate muscle relaxation.
Study procedure in Group A:
When the muscles are completely relaxed, by using a laryngo-tracheal mucosal atomization device 2 mL of study drug (0.75% ropivacaine) instilled intratracheally to allow uniform surface anesthesia. After study drug instillation, the patient will be intubated using endotracheal tube 7.0–7.5 mm ID for female patients and 7.5–8.5 mm ID for male patients. Intubation will be performed by direct laryngoscopy. After ensuring the proper position of the endotracheal tube, the cuff will be inflated with air.
Study procedure in Group C:
After achieving complete muscle relaxation, using direct laryngoscopy, patient will be intubated using endotracheal tube of 7.0-7.5 mm ID for female patients and 7.5-8.5mm ID for male patients. After ensuring the proper position of the endotracheal tube, the cuff will be inflated with 3ml of study drug (0.75% ropivacaine).
Surgery will be carried out, during extubation time we want to see the heart rate, blood pressure changes and post operative sore throat and cough will be evaluated.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient undergoing various elective surgeries under general anaesthesia.
- •Age between 18-65 years old
- •American Society of Anaesthesiologists (ASA) I & II.
排除标准
- •1.Patients known allergic to the local anaesthetic drugs.
- •2.Patients undergoing emergency procedures.
- •Haemodynamically unstable patients & pregnant patients.
- •Patients with pre-existing sore throat, hoarseness, cough, recent respiratory illness or history of airway hyperactivity
- •Patients with a difficult airway where the anticipated duration of laryngoscopy exceeds 15 seconds.
- •Patients with a history of cardiac, liver or renal diseases.
结局指标
主要结局
HR,BP will be rising during the time of extubation, which will be blunted in this study. Post operative sore throat and cough will not be there.
时间窗: During extubation to immediated post operative period upto 2 hours
次要结局
- To compare the effect of intra-cuff ropivacaine (0.75%) versus intratracheal instillation of ropivacaine (0.75%) using atomizer on post operative sore throat and cough.(Immediate post operative period)
研究者
DR Kathija Begam A
Jawaharlal Nehru Medical College