Blood Pressure After Nerve BlockNCT07627100
COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION
A study testing Nebulized Lidocaine and Nerve Block in people with Blood Pressure After Nerve Block and Hemodynamic Stability During Awake Intubation, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This prospective randomized controlled trial aims to compare the effectiveness of airway nerve blocks versus nebulized lidocaine in attenuating hemodynamic responses during awake fiberoptic intubation in adult patients with anticipated difficult airways. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Pressure After Nerve Block, Hemodynamic Stability During Awake Intubation
- What is being tested?
- Nebulized Lidocaine and Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years. American Society of Anesthesiologists (ASA) physical status I-III. Scheduled for elective surgery requiring awake fiberoptic intubation. Anticipated difficult airway. Able and willing to provide written informed consent
Who cannot join
- Known allergy or hypersensitivity to lidocaine or other local anesthetics. Coagulopathy or bleeding disorders. Severe respiratory disease. Hemodynamic instability. Pregnancy. Refusal to participate in the study. Inability to cooperate with awake fiberoptic intubation or study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION, A RANDOMIZED CONTROLLED TRIAL
This prospective randomized controlled trial aims to compare the effectiveness of airway nerve blocks versus nebulized lidocaine in attenuating hemodynamic responses during awake fiberoptic intubation in adult patients with anticipated difficult airways. Eighty patients undergoing elective surgery requiring awake fiberoptic intubation will be randomly assigned to receive either airway nerve blocks (glossopharyngeal and transtracheal blocks with lidocaine) or nebulized lidocaine. The primary outcome will be changes in heart rate and mean arterial pressure during and after intubation. Secondary outcomes include intubation conditions, patient comfort, cough severity, intubation time, and procedure-related complications. The study aims to identify the most effective airway anesthesia technique for maintaining hemodynamic stability and improving patient tolerance during awake fiberoptic intubation.
- Being tested
- Nebulized Lidocaine, Nerve Block
- Keywords
- Awake intubation, Nerve block, Nebulized lignocaine, Fibreoptic, Hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized LidocaineDrug
Participants will receive 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation to provide topical airway anesthesia and suppress airway reflexes during the procedure.
Nerve BlockProcedure or surgery
Participants will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine before awake fiberoptic intubation to provide airway anesthesia and suppress airway reflexes during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Lidocaine | Experimental | Participants allocated to this arm will receive airway topical anesthesia using 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Additional outcomes including intubation time, patient comfort, cough severity, and procedure-related complications will be assessed. Receives: Drug: Nebulized Lidocaine |
| Nerve Block | Experimental | Participants allocated to this arm will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine prior to awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Secondary outcomes including intubation time, patient comfort score, cough severity, and procedure-related complications will also be assessed. Receives: Procedure: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic Intubation
Change in mean arterial pressure from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
Measured: Baseline to 5 minutes after intubation.
Heart Rate Change During Awake Fiberoptic Intubation
Change in heart rate from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
Measured: Baseline to 5 minutes after intubation.
Secondary outcomes (5)
Intubation Time
Time from insertion of the fiberoptic bronchoscope until confirmation of successful endotracheal tube placement.
Measured: During the intubation procedure.
Patient Comfort Score
Patient comfort assessed using a standardized 5-point tolerance scale.
Measured: Immediately after completion of awake fiberoptic intubation.
Cough Severity Score
Severity of coughing during awake fiberoptic intubation assessed using a predefined cough scoring system.
Measured: During the intubation procedure.
Successful Intubation Rate
Successful placement of an endotracheal tube without the need for rescue airway anesthesia.
Measured: From intervention administration until 5 minutes after intubation.
Procedure-Related Complications
Incidence of adverse events including airway trauma, desaturation, allergic reactions, hoarseness, or other procedure-related complications.
Measured: From intervention administration until 5 minutes after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start28 Jun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure After Nerve BlockStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aniqa Intizar, Mayo Hospital Lahore
- Investigators
- Aniqa Intizar, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627100
- Sponsor's protocol ID
- Nerve Block Intubation
- Status last verified
- Apr 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION, A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07627100
- Acronym / sponsor ID
- Nerve Block Intubation
- Keywords
- Awake intubation, Nerve block, Nebulized lignocaine, Fibreoptic, Hemodynamic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
This prospective randomized controlled trial aims to compare the effectiveness of airway nerve blocks versus nebulized lidocaine in attenuating hemodynamic responses during awake fiberoptic intubation in adult patients with anticipated difficult airways. Eighty patients undergoing elective surgery requiring awake fiberoptic intubation will be randomly assigned to receive either airway nerve blocks (glossopharyngeal and transtracheal blocks with lidocaine) or nebulized lidocaine. The primary outcome will be changes in heart rate and mean arterial pressure during and after intubation. Secondary outcomes include intubation conditions, patient comfort, cough severity, intubation time, and procedure-related complications. The study aims to identify the most effective airway anesthesia technique for maintaining hemodynamic stability and improving patient tolerance during awake fiberoptic intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Lidocaine | Experimental | Drug: Nebulized LidocaineParticipants allocated to this arm will receive airway topical anesthesia using 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Additional outcomes including intubation time, patient comfort, cough severity, and procedure-related complications will be assessed. |
| Nerve Block | Experimental | Procedure: Nerve BlockParticipants allocated to this arm will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine prior to awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Secondary outcomes including intubation time, patient comfort score, cough severity, and procedure-related complications will also be assessed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 65 years. American Society of Anesthesiologists (ASA) physical status I-III. Scheduled for elective surgery requiring awake fiberoptic intubation. Anticipated difficult airway. Able and willing to provide written informed consent
Key exclusion criteria (1 listed)
- Known allergy or hypersensitivity to lidocaine or other local anesthetics. Coagulopathy or bleeding disorders. Severe respiratory disease. Hemodynamic instability. Pregnancy. Refusal to participate in the study. Inability to cooperate with awake fiberoptic intubation or study procedures
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 |
|---|---|---|
| Nebulized LidocaineParticipants will receive 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation to provide topical airway anesthesia and suppress airway reflexes during the procedure. | Drug | Nebulized Lidocaine |
| Nerve BlockParticipants will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine before awake fiberoptic intubation to provide airway anesthesia and suppress airway reflexes during the procedure. | Procedure or surgery | Nerve Block |
Primary outcome
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic Intubation
Time frame: Baseline to 5 minutes after intubation.
Change in mean arterial pressure from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
Heart Rate Change During Awake Fiberoptic Intubation
Time frame: Baseline to 5 minutes after intubation.
Change in heart rate from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
5 secondary outcomes
Intubation Time
Time frame: During the intubation procedure.
Patient Comfort Score
Time frame: Immediately after completion of awake fiberoptic intubation.
Cough Severity Score
Time frame: During the intubation procedure.
Successful Intubation Rate
Time frame: From intervention administration until 5 minutes after intubation.
Procedure-Related Complications
Time frame: From intervention administration until 5 minutes after intubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
Aniqa Intizar principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized Lidocaine and Nerve Block in people with Blood Pressure After Nerve Block and Hemodynamic Stability During Awake Intubation, run by Mayo Hospital Lahore 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aniqa Intizar (+923349872530, aniqaintizar1040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic Intubation (time frame: Baseline to 5 minutes after intubation.). The study lists 2 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 4 Jun 2026.