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

NCT ID: NCT07084623

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-01

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.

Conditions

Lignocaine; Anesthesia, Local; Trachea; Airway Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Pre-procedure lignocaine spray (PPL)

Intervention Type: 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)

Intervention Type: 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

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

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

Group Type: ACTIVE_COMPARATOR

Pre-procedure lignocaine spray (PPL)

Intervention Type: 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)

Intervention Type: 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

Interventions

Pre-procedure lignocaine spray (PPL)

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)

Intervention Type: DRUG

Lignocaine Spray (Spray-as-you-go)

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

Intervention Type: DRUG

Eligibility Criteria

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%)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Zayed Federal Postgraduate Medical Institute

OTHER

Sponsor Role: lead

Responsible Party

Talha Mahmud

Professor of Pulmonology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talha Mahmud, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Hira Ishtiaq, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Shaikh Zayed Hospital, Federal Postgraduate Medical Institute

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

SheikhZayedFederalPMER

Identifier Type: -

Identifier Source: org_study_id