LignocaineNCT07084623
Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy
A study testing Pre-procedure lignocaine spray (PPL) and Lignocaine Spray (Spray-as-you-go) in people with Lignocaine and Anesthesia, Local, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Lignocaine, Anesthesia, Local, Trachea
- What is being tested?
- Pre-procedure lignocaine spray (PPL) and Lignocaine Spray (Spray-as-you-go)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaikh Zayed Hospital, Federal Postgraduate Medical Institute
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy: A Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Pre-procedure lignocaine spray (PPL), Lignocaine Spray (Spray-as-you-go)
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Pre-procedure lignocaine spray (PPL); Drug: Lignocaine Spray (Spray-as-you-go) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient discomfort and operator comfort during fiberoptic bronchoscopy
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Secondary outcomes (1)
Procedure duration
Comparison of procedure duration between PPL and SAYG airway anesthesia methods, measured in minutes from scope insertion to withdrawal.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LignocaineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled trial was conducted at the Pulmonology Department of Shaikh Zayed Hospital, Lahore, Pakistan, from March 2021 to March 2022.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Mahmud, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Talha Mahmud, PhD, Principal investigator, Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.Hira Ishtiaq, MD, Principal investigator, Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084623
- Sponsor's protocol ID
- SheikhZayedFederalPMER
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-procedure Lignocaine Spray Versus Spray-as-you-go for Topical Airway Anesthesia in Flexible Bronchoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07084623
- Acronym / sponsor ID
- SheikhZayedFederalPMER
- Conditions
- Lignocaine, Anesthesia, Local, Trachea, Airway Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-blind randomized controlled trial was conducted at the Pulmonology Department of Shaikh Zayed Hospital, Lahore, Pakistan, from March 2021 to March 2022.
| Arm | Type | Receives |
|---|---|---|
| Pre-procedure lignocaine spray (PPL) | Active comparator | 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. 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 | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Pre-procedure lignocaine spray (PPL), Spray-as-you-go (SAYG) Airway Anesthesia |
| 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 | Drug | Pre-procedure lignocaine spray (PPL), Spray-as-you-go (SAYG) Airway Anesthesia |
Primary outcome
Patient discomfort and operator comfort during fiberoptic bronchoscopy
Time frame: 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 techniques
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.
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-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.
1 secondary outcome
Procedure duration
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talha Mahmud, PhD principal investigator
Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.
Hira Ishtiaq, MD principal investigator
Shaikh Zayed Medical Complex, Federal Postgraduate Medical Institute, Lahore Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-procedure lignocaine spray (PPL) and Lignocaine Spray (Spray-as-you-go) in people with Lignocaine and Anesthesia, Local, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient discomfort and operator comfort during fiberoptic bronchoscopy (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.