Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .
研究概览
简要总结
One of the most common complications after endotracheal intubation is sore throat Lidocaine jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for prophylaxis against POST are expensive ,and having much more side effects,but nebulized lidocaine is easily found with decreasing cost ,easily administered ,acts immediately with short duration ,minimal side effects ,and no term residual side effects.
Nebulized ketamine was found to have a protective effect on allergen-induced airway inflammatory injury , high airway reactivity ,and decreasing postoperative sore throat (POST) incidence .
Magnesium sulfate is similar to ketamine in blocking the N-methyl-D-aspartate receptors.
详细描述
Patients and Methods a) Sample size:Assuming that mean+standard Deviation of age of nebulized ketamine group is 42.3+11.9 and normal saline group is 35.5+11.7 .So sample size is calculated by open source Epidemiologic statistics for public health (openEpi) to be 100 cases in 4 groups (25 cases in each group) with confidence level 95% and power of test is 80%.
All Cases Will Undergo:
a. Patient Examination: All participating patients will be interviewed preoperatively during their preoperative preparation. The goal and endpoints of the study will be discussed. and written informed consent will be included in the study.
On physical examination, special attention will be given to document vital signs, cardiac, chest condition and exclude exclusion criteria , laboratory investigations will be reviewed ..
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •Age (21-45) years old.
- •American Society of Anesthesiologists (ASA) I / II
- •elective surgery of approximately 2-3h duration needing endotracheal intubation
- •Patient With BMI(Body Mass Index)(25-30)
排除标准
- •Patient refusal.
- •Altered mental status.
- •History of allergy to drugs in the study
- •.Patients with history of pervious sore throat
- •using steroids or NSAIDs,with asthma
- •neuromuscular disease
- •, Mallampati grade>2, with >2 attempts of intubations,
- •underlying neck ,and laparoscopic surgeries,
- •pregnant women.
研究组 & 干预措施
Group (K)
Group (K) (n=25): patients nebulized ketamine 50 mg(milgram) (1ml) plus 4ml normal saline.So total volume (5ml).
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized 1ml ketamine (Ketalar 50mg/VI Solution for Injection) by compressor nebulizing for 15 minutes.
干预措施: Ketamine (Drug)
Group (M)
Group M(n=25) : patients nebulized isotonic magnesium sulfate 250mg (3ml)( 50% Magnesium Sulfate Injection)plus 1ml normal saline.
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes.
干预措施: Magnesium Sulfate (Drug)
Group (L)
Group (L) (n=25): patients nebulized lidocaine 2% 100mg .So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes.
干预措施: Lidocaine (Drug)
Group (C)
Group (C) (n=25): patients nebulized normal saline(0.9%). 5ml .In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes.
干预措施: Normal saline (Drug)
结局指标
主要结局
4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .
时间窗: 2,4,8,12,24 hours
The intensity of sore throat will be recorded at 2,4,8,12,24 hours postoperatively on 4 point scale (0-3): 0= no sore throat 1. mild sore throat (complaint of sore throat on asking). 2. moderate sore throat (change in voice or hoarseness associated with throat pain). 3. sever sore throat (change in voice or hoarseness associated with throat pain).
次要结局
未报告次要终点
研究者
Alshaimaa Abdel Fattah Kamel
lectuerer
Zagazig University