Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy
- Conditions
- LignocaineAnesthesia, LocalTracheaAirway Disease
- Interventions
- Drug: Pre-procedure lignocaine spray (PPL)Drug: Lignocaine Spray (Spray-as-you-go)
- Registration Number
- NCT07084623
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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%)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pre-procedure lignocaine spray (PPL) Pre-procedure lignocaine spray (PPL) Participants received: 1. Standard sedation with midazolam (0.01 mg/kg IV); 2. 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy; 3. 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 Pre-procedure lignocaine spray (PPL) Lignocaine Spray (Spray-as-you-go) Participants received: 1. Standard sedation with midazolam (0.01 mg/kg IV); 2. 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy; 3. 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 Spray-as-you-go (SAYG) Airway Anesthesia Pre-procedure lignocaine spray (PPL) Participants received: 1. Standard sedation with midazolam (0.01 mg/kg IV); 2. 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy; 3. 2% lignocaine spray (3 mg/kg) during procedure: * Initial 2-4 mL sprayed over vocal cords * Additional doses in mainstem bronchi during scope advancement Spray-as-you-go (SAYG) Airway Anesthesia Lignocaine Spray (Spray-as-you-go) Participants received: 1. Standard sedation with midazolam (0.01 mg/kg IV); 2. 2 mL of 4% lignocaine spray in the oropharynx before bronchoscopy; 3. 2% lignocaine spray (3 mg/kg) during procedure: * Initial 2-4 mL sprayed over vocal cords * Additional doses in mainstem bronchi during scope advancement
- Primary Outcome Measures
Name Time Method Patient discomfort and operator comfort during fiberoptic bronchoscopy 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 techniques4-point Likert scale 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 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 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.
- Secondary Outcome Measures
Name Time Method Procedure duration One year Comparison of procedure duration between PPL and SAYG airway anesthesia methods, measured in minutes from scope insertion to withdrawal.
Trial Locations
- Locations (1)
Shaikh Zayed Hospital, Federal Postgraduate Medical Institute
🇵🇰Lahore, Punjab, Pakistan
Shaikh Zayed Hospital, Federal Postgraduate Medical Institute🇵🇰Lahore, Punjab, Pakistan