Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient discomfort and operator comfort during fiberoptic bronchoscopy
研究概览
简要总结
Title: Comparing Two Methods of Topical Anesthesia for Fiberoptic Bronchoscopy
Purpose: To compare the effectiveness of two methods of anesthesia, pre-procedure lignocaine spray (PPL) and spray-as-you-go (SAYG), in reducing discomfort and improving operator comfort during fiberoptic bronchoscopy.
Study Design: Randomized controlled trial Participants: 50 patients undergoing fiberoptic bronchoscopy Interventions: Patients received either PPL or SAYG anesthesia
Outcomes:
- Pain perception
- Cough severity
- Operator comfort
- Procedure duration
Results:
- Both PPL and SAYG methods were effective in reducing pain and discomfort
- No significant differences were observed between the two groups in pain perception, cough scores, or procedure duration
- Operator comfort scores showed a trend favoring PPL, but the difference was not statistically significant
Implications: Both PPL and SAYG methods can be effectively used for fiberoptic bronchoscopy, with potential implications for procedural efficiency and patient outcomes.
详细描述
A single-blind RCT included 50 participants were randomly assigned to two groups (n = 25 each). Standard procedural sedation with midazolam and 2 mL of 4% lignocaine spray in the oropharynx was used to suppress the gag reflex. Additionally, 2% lignocaine spray was administered during the procedure according to body weight (3 mg/kg) via oral scope insertion. Cough severity, pain perception, and operator comfort were assessed using the Visual Analogue Scale, Faces Pain Rating Scale, and a 4-point Likert scale, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients indicated for diagnostic bronchoscopy, aged over 18 years, both genders (males and females), hemodynamically stable (defined as systolic blood pressure between 100 and 180 mm Hg), and sedated with an intravenous injection of midazolam at 0.01 mg/kg.
排除标准
- •Hypersensitivity to lignocaine, use of general anesthesia for the procedure or other emergency procedures, pregnancy, comorbidities such as heart failure, advanced chronic kidney disease stage 3-4, chronic liver disease, contraindications to sedation, and hypoxemia (oxygen saturation by pulse oximetry, SpO2 < 92%)
研究组 & 干预措施
Pre-procedure lignocaine spray (PPL)
Participants received:
- Standard sedation with midazolam (0.01 mg/kg IV);
- 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy;
- Additional 2% lignocaine spray (3 mg/kg):
- 2-4 mL sprayed over vocal cords via bronchoscope working channel
- Remaining dose as single bolus into larynx/trachea
干预措施: Pre-procedure lignocaine spray (PPL) (Drug)
Pre-procedure lignocaine spray (PPL)
Participants received:
- Standard sedation with midazolam (0.01 mg/kg IV);
- 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy;
- Additional 2% lignocaine spray (3 mg/kg):
- 2-4 mL sprayed over vocal cords via bronchoscope working channel
- Remaining dose as single bolus into larynx/trachea
干预措施: Lignocaine Spray (Spray-as-you-go) (Drug)
Spray-as-you-go (SAYG) Airway Anesthesia
Participants received:
- Standard sedation with midazolam (0.01 mg/kg IV);
- 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy;
- 2% lignocaine spray (3 mg/kg) during procedure:
- Initial 2-4 mL sprayed over vocal cords
- Additional doses in mainstem bronchi during scope advancement
干预措施: Pre-procedure lignocaine spray (PPL) (Drug)
Spray-as-you-go (SAYG) Airway Anesthesia
Participants received:
- Standard sedation with midazolam (0.01 mg/kg IV);
- 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy;
- 2% lignocaine spray (3 mg/kg) during procedure:
- Initial 2-4 mL sprayed over vocal cords
- Additional doses in mainstem bronchi during scope advancement
干预措施: Lignocaine Spray (Spray-as-you-go) (Drug)
结局指标
主要结局
Patient discomfort and operator comfort during fiberoptic bronchoscopy
时间窗: One year
This composite outcome evaluates three distinct parameters: 1. Cough severity measured by the Visual Analog Scale (100-mm scale where 0 mm indicates no cough and 100 mm indicates worst possible cough, with higher scores representing worse severity); 2. Pain perception assessed via the Faces Pain Rating Scale (11-point scale from 0 \[no pain\] to 10 \[worst imaginable pain\], where higher scores indicate worse pain); and 3. Operator comfort rated on a 4-point Likert scale (1 = Not comfortable to 4 = Very comfortable, with higher scores reflecting better comfort). All measures will be analyzed separately to compare PPL and SAYG techniques
4-point Likert scale
时间窗: One year
Operator comfort assessed via 4-point Likert scale where 1 = Not comfortable, 2 = Slightly uncomfortable, 3 = Comfortable, and 4 = Very comfortable. Higher scores indicate better comfort.
Visual Analogue Scale
时间窗: One year
Cough severity measured using 100-mm Visual Analog Scale where 0 mm = no cough and 100 mm = worst cough imaginable. Higher scores indicate worse cough severity.
Faces Pain Rating Scale
时间窗: One year
Pain intensity measured using Faces Pain Rating Scale (0-10) where 0 = no pain and 10 = worst pain possible. Higher scores indicate worse pain.
次要结局
- Procedure duration(One year)
研究者
Talha Mahmud
Professor of Pulmonology
Sheikh Zayed Federal Postgraduate Medical Institute