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

NCT07084623 | Completed

• 1 other identifier: SheikhZayedFederalPMER
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lignocaine; Anesthesia, Local; Trachea; Airway Disease

Outcome Measures

Primary Outcomes (4)

• Patient discomfort and operator comfort during fiberoptic bronchoscopy

  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

  One year

• Visual Analogue Scale

  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.

  One year

• Faces Pain Rating Scale

  Pain intensity measured using Faces Pain Rating Scale (0-10) where 0 = no pain and 10 = worst pain possible. Higher scores indicate worse pain.

  One year

• 4-point Likert scale

  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.

  One year

Secondary Outcomes (1)

• Procedure duration

  One year

Other Outcomes (3)

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

  One year

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

  One year

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

  One year

Study Arms (2)

Pre-procedure lignocaine spray (PPL)

ACTIVE COMPARATOR

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

Drug: Pre-procedure lignocaine spray (PPL); Drug: Lignocaine Spray (Spray-as-you-go)

Spray-as-you-go (SAYG) Airway Anesthesia

ACTIVE COMPARATOR

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

Drug: Pre-procedure lignocaine spray (PPL); Drug: Lignocaine Spray (Spray-as-you-go)

Interventions

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)

Pre-procedure lignocaine spray (PPL); Spray-as-you-go (SAYG) Airway Anesthesia

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

Pre-procedure lignocaine spray (PPL); Spray-as-you-go (SAYG) Airway Anesthesia

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

Study Sites (1)

Shaikh Zayed Hospital, Federal Postgraduate Medical Institute

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Talha Mahmud, PhD

  Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.

  PRINCIPAL INVESTIGATOR

• Hira Ishtiaq, MD

  Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonology

Model Details: A single-blind randomized controlled trial was conducted at the Pulmonology Department of Shaikh Zayed Hospital, Lahore, Pakistan, from March 2021 to March 2022.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 24, 2025
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)