Preoperative Nebulized Lidocaine, Mouth Rinsing, and Gargling Versus Intravenous Fentanyl to Obtund the Stress of Intubation Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum change in systolic blood pressure 5 minutes after endotracheal intubation from the baseline in both groups.
研究概览
简要总结
To compare the effectiveness of preoperative combined topical airway anesthesia consisting of nebulised, mouth rinsing and gargling with lidocaine versus intravenous fentanyl to prevent the stress of endotracheal intubation by direct laryngoscopy under general anesthesia.
详细描述
Methodology
I. Study design Prospective randomized controlled trial. II. Study setting and location The study will be conducted in Kasr Al-Aini hospital (Cairo university hospitals) in elective surgical theatres.
III. Study population The study will be conducted on all elective surgical patients aged from 18 to 60 years requiring endotracheal intubation by direct laryngoscopy.
Total number of patients is 50 divided into two equal groups each containing 25 patients The two groups are group L (lidocaine) and group F (fentanyl). IV. Eligibility Criteria
- Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anaesthesiologists class 1 or 2 (ASA 1 or 2) patients.
- •Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation using direct laryngoscope.
- •Population aged from 18 to 60 years.
排除标准
- •Patient's refusal to participate.
- •ASA class 3 or more patients including Substantive functional limitations; One or more moderate to severe diseases. Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, history of MI, CVA, TIA, or CAD/stents, asthma with exacerbation, poorly controlled epilepsy.
- •Patients with any degree of Hypertension or treated for hypertension.
- •Pregnant patients.
- •Age of participant less than 18 or more than 60 years.
- •History of allergy to local anaesthetics or opioids.
- •Opioid abuse
- •Anticipated difficult airway which will be defined as El-Ganzouri Risk Index (EGRI) score of 4 or more points.
- •Difficult intubation which will be defined as situation where proper insertion of the tracheal tube with conventional laryngoscopy requires more than three attempts or more than 10 min.
- •Difficult mask ventilation which will be defined as a situation that develops when it is not possible for the unassisted anaesthesiologist to maintain the oxygen saturation >90% using 100% oxygen and positive pressure ventilation, or to prevent or reverse signs of inadequate ventilation.
- •Patients requiring more than one attempt of intubation.
- •Intubation time more than 30 seconds.
- •Emergency surgeries or patients requiring rapid sequence induction for other reasons.
研究组 & 干预措施
iv fentanyl
iv fentanyl dose 1 microgram per kg just before induction drug :Fentanyl citrate (0.05 mg/ml) (Fentanyl Hameln pharmaceutical, Germany) (Low Dose) low dose fentanyl iv 1 microgram per kg before induction
干预措施: Fentanyl (Low Dose) (Drug)
Topical lidocaine
nebulized lidocaine + mouth rinse + gargling dose 4.5mg per kg given pre-operatively drug topical lidocaine 2% topical lidocaine nebulized for 10 min + mouth rinsing and gargling for 3 min
干预措施: topical lidocaine (Drug)
结局指标
主要结局
Maximum change in systolic blood pressure 5 minutes after endotracheal intubation from the baseline in both groups.
时间窗: within 5 minutes post-intubation
Automated non-invasive blood pressure monitor was used.
次要结局
未报告次要终点
研究者
Zeinab Mohamed Gamal El Deen Megaly
Residents
Kasr El Aini Hospital