An interventional study of Pre-procedure lignocaine spray (PPL) and Lignocaine Spray (Spray-as-you-go) in Lignocaine, Anesthesia, Local and Trachea, sponsored by Sheikh Zayed Federal Postgraduate Medical Institute. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Sheikh Zayed Federal Postgraduate Medical Institute · Not applicable, Interventional, and Treatment
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:
Results:
Implications: Both PPL and SAYG methods can be effectively used for fiberoptic bronchoscopy, with potential implications for procedural efficiency and patient outcomes.
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.
33 studies on the registry are indexed under Tracheal Diseases; 7 are open to participants now.
This study's enrollment of 50 is above the median of 34 across 22 interventional studies indexed under Tracheal Diseases.
Browse Tracheal Diseases studies →Sheikh Zayed Federal Postgraduate Medical Institute is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One year
Procedure duration
Comparison of procedure duration between PPL and SAYG airway anesthesia methods, measured in minutes from scope insertion to withdrawal.
Time frame: One year
Comparative effectiveness of PPL versus SAYG anesthesia in cough suppression using the Visual Analog Scale (VAS)
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.
Time frame: One year
Comparative effectiveness of PPL versus SAYG anesthesia in pain control using the Faces Pain Rating Scale (FPRS)
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.
Time frame: One year
Comparative effectiveness of PPL versus SAYG anesthesia in operator comfort using the Operator Likert Scale
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.
Time frame: One year
Plan to share: No
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Ran from Mar 2021 to primary completion in Mar 2022, 12 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Sheikh Zayed Federal Postgraduate Medical Institute