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Completed

NCT Number: NCT07084623

Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy

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.

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Key information

Conditions

Lignocaine Airway Disease Anesthesia, Local Respiratory Tract Diseases Trachea Tracheal Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Hospital, Federal Postgraduate Medical Institute

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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%)

Treatment and study plan

Pre-procedure lignocaine spray (PPL)

Drug

Administration of 2 mL of 4% lignocaine spray in the oropharynx before the fiberoptic bronchoscopy procedure, followed by additional 2% lignocaine spray according to body weight (3 mg/kg)

Lignocaine Spray (Spray-as-you-go)

Drug

Administration of 2% lignocaine spray via oral scope insertion during the fiberoptic bronchoscopy procedure, according to body weight (3 mg/kg), with standard procedural sedation with midazolam and initial 2 mL of 4% lignocaine spray in the oropharynx for gag reflex suppression

Primary outcomes

  1. Patient discomfort and operator comfort during fiberoptic bronchoscopy

    Time frame: One year

    This composite outcome evaluates three distinct parameters:

    • 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);
    • 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
    • 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

  2. Visual Analogue Scale

    Time frame: 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.

  3. Faces Pain Rating Scale

    Time frame: 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.

  4. 4-point Likert scale

    Time frame: 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.

Secondary outcomes

  1. Procedure duration

    Time frame: One year

    Comparison of procedure duration between PPL and SAYG airway anesthesia methods, measured in minutes from scope insertion to withdrawal.

Other outcomes

  1. Comparative effectiveness of PPL versus SAYG anesthesia in cough suppression using the Visual Analog Scale (VAS)

    Time frame: One year

    This study will compare the effectiveness of pre-procedure lignocaine spray (PPL) and spray-as-you-go (SAYG) techniques in suppressing cough, measured by the Visual Analog Scale (VAS). The VAS is a 100-mm scale where 0 = no cough and 100 = worst cough, with higher scores indicating worse outcomes.

  2. Comparative effectiveness of PPL versus SAYG anesthesia in pain control using the Faces Pain Rating Scale (FPRS)

    Time frame: One year

    This study will compare the effectiveness of PPL and SAYG techniques in pain control, assessed via the Faces Pain Rating Scale (FPRS). The FPRS is a 0-10 scale where 0 = no pain and 10 = worst pain, with higher scores indicating worse outcomes.

  3. Comparative effectiveness of PPL versus SAYG anesthesia in operator comfort using the Operator Likert Scale

    Time frame: One year

    This study will compare the effectiveness of PPL and SAYG techniques in operator comfort, evaluated using a 4-point Likert scale (1 = Not comfortable, 4 = Very comfortable), with higher scores indicating better outcomes.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Other

Registry information

Official study title

Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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