Comparison of efficacy of pre-operative nebulized magnesium sulphate versus lidocaine on the prevention of post-intubation sore throat: a randomised control study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the Post-operative Sore throat after Extubation at rest and on swallowing
研究概览
简要总结
| All patients will be kept fasting overnight and pre medicated with oral tablet alprazolam 0.5mg and tablet ranitidine 150mg on night before surgery. |
In the preparation room, intravenous line will be secured and standard monitors will be connected (Electrocardiogram – ECG, non-invasive blood pressure and pulse oximetry) and baseline parameters such as heart rate (HR), systolic & diastolic blood pressure (BP) and peripheral oxygen saturation (spo2) will be noted.
| Before induction of general anesthesia, 80 patients will be divided randomly by computer-generated randomization table into 2 groups each was 40.www.randomization.com. |
Patients will be nebulized in sitting position through piston type compressor nebulizer for 15 min, 30 mins prior to the induction of general anesthesia.
· Group (M) (n=40): patients nebulized with magnesium sulfate 250mg (2.5ml) plus sterile water (2.5ml). Total volume 5ml.
· Group (N) (n=40): patients nebulized with lidocaine 2% 100mg (5ml)
Total volume 5ml.
The drugs will be loaded by nursing staff and will be blinded to the investigator and patient.
After nebulization, the patient will be transferred to the operating room, standard monitors will be applied (ECG, noninvasive blood pressure and pulse oximetry). Patient will be pre-oxygenated with 5 L/min oxygen (O2) 100% for 3 minutes. Induction will be done with fentanyl 2μg/kg and propofol 2mg/kg. Endotracheal intubation will be facilitated by Vecuronium 0.1 mg/kg. Smooth laryngoscopy and intubation will be performed by an experienced anesthesiologist using cuffed soft seal sterile polyvinyl chloride tracheal tube of 7-mm inner diameter for female and 8 mm for male patients. The cuff will be inflated with air and the pressure in the cuff was maintained between 20 and 22 cm H2O using a pressure manometer. To prevent the mucosal dryness we will use heat and humidifier moisture exchanger (HME). Maintenance of anesthesia will be done using isoflurane 1.2% in oxygen: air 50:50%. Maintenance doses of Vecuronium 0.25 mg/kg. Inj. Paracetamol 15 mg/kg IV is given.
Hemodynamic parameters like MAP, SBP, DBP, SPO2 and HR will be observed immediate post-intubation, 2minutes, 5 minutes, 10minutes post-intubation and 5 minutes interval till 30 minute and 15 minutes interval till extubation.
On completion of surgery, anesthetic agents will be discontinued allowing recovery of consciousness. The muscle relaxation will be reversed with a combination of neostigmine 0.05 mg/ kg and glycopyrrolate 0.01 mg/kg. The patient will be smoothly extubated without bucking on the endotracheal tube after extubation criteria are met, and the patients will be shifted to post anaesthesia care unit.
The intensity of sore throat will be recorded at 0 h (on arrival to post-anesthesia care unit(PACU)), 4h, 8h, 12h, 24h and 48h postoperatively.
These symptoms will be scored by the investigator who will be blinded to the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patient willing to give informed written consent 2 Adult normotensive patients aged between 18 to 60 years posted for surgery 3 American society of Anaesthesiology (ASA) grade 1 or 2.
排除标准
- •1 Patients scheduled for surgeries under General anaesthesia more than 4hrs duration 2 Patients with neuromuscular disease, cardio vascular, respiratory, renal and hepatic derangement 3 Patients has allergy or hypersensitivity to drugs 4 Attempt of nasogastric tube pre-operatively and intra-operatively 5 Patients undergoing head and neck surgery, laparoscopic surgery, prone positing during surgery.
- •Patient with incidence of post laryngospasm.
- •7 Patient with anticipated or attempted difficult intubation.
- •8 Patient intubated with any maneuver other than laryngoscope eg; i-gel, laryngeal mask airway or fiber-optic guided.
- •9 Patient with history of pre-operative sore throat, using steroid, or analgesic in last 48h 10 Pregnant women, psychiatric illness.
结局指标
主要结局
To compare the Post-operative Sore throat after Extubation at rest and on swallowing
时间窗: IMMEDIATE POSTOP 4 hours , 8 hours, 12 hours, 24 hours and 48 hours
次要结局
- To look for other side effects like nausea vomiting sedation cough laryngospasam hoarseness of voice dysphagia dysphonia
研究者
DR. E. R. Revaanth
Bangalore Medical College and Research Institute.