To study and compare the efficacy of preoperative Magnesium Sulphate nebulization with Ketamine nebulization In reducing the incidence and severity of post-operative pharyngolaryngeal complications - A prospective triple blinded randomised controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- a. Extubation Quality using 5 point extubation quality score.
研究概览
简要总结
We will be nebulizing patients with magnesium sulfate 250mg and ketamine 50mg over 15 minutes and then follow up patients for developing pharnygolaryngeal complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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.Males and females between the age group 18-60 years.
- •ASA class I-II.
- •Body mass index(BMI) 18.5-29.
- •Undergoing surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes.
排除标准
- •Patient’s refusal participation in study.
- •Haemodynamically unstable patients.
- •History of hypertension, asthma, chronic obstructive pulmonary disease(COPD), cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease.
- •Patients having known hypersensitivity to drugs under consideration.
- •Patient with three or more attempts at laryngoscopy or bougie for intubation.
- •Patients who sustained trauma while intubation or nasogastric tube insertion as evidenced by blood on cuff after extubation or blood stained secretions while suctioning before extubation.
- •Patient suffering from active or recent (past 6 weeks) upper airway tract infection (preoperative sore throat, cough) and edema/inflammation noticed during laryngoscopy.
- •Surgery requiring placement of nasogastric tube intraopeartively.
- •Patients already on analgesics or steroids (systemic or inhaled).
结局指标
主要结局
a. Extubation Quality using 5 point extubation quality score.
时间窗: 2,4,6,12,24,48 hours
b. Post extubation airway related adverse effects like cough (POC), sore throat (POST) & hoarseness (POH).
时间窗: 2,4,6,12,24,48 hours
3. To study side effect of study drugs if any.
时间窗: 2,4,6,12,24,48 hours
4. Patient satisfaction score.
时间窗: 2,4,6,12,24,48 hours
PRIMARY OBJECTIVES
时间窗: 2,4,6,12,24,48 hours
1. To Evaluate & compare the effectiveness of nebulised Magnesium sulfate & ketamine in:
时间窗: 2,4,6,12,24,48 hours
2. To access the airway dynamics during surgery & extubation.
时间窗: 2,4,6,12,24,48 hours
SECONDARY OBJECTIVES
时间窗: 2,4,6,12,24,48 hours
1. To access the haemodynamic parameter during surgery & extubation.
时间窗: 2,4,6,12,24,48 hours
次要结局
- SECONDARY OBJECTIVES(1.To access the haemodynamic parameter during surgery and extubation.)