Mayo Hospital, Lahore
Lahore, Punjab Province, 54000, Pakistan
Not Yet Recruiting
NCT Number: NCT07627100
COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
Treatment and study plan
Nebulized Lidocaine
DrugParticipants 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 Block
ProcedureParticipants 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.
Primary outcomes
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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.
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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.
Secondary outcomes
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Intubation Time
Time frame: During the intubation procedure.
Time from insertion of the fiberoptic bronchoscope until confirmation of successful endotracheal tube placement.
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Patient Comfort Score
Time frame: Immediately after completion of awake fiberoptic intubation.
Patient comfort assessed using a standardized 5-point tolerance scale.
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Cough Severity Score
Time frame: During the intubation procedure.
Severity of coughing during awake fiberoptic intubation assessed using a predefined cough scoring system.
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Successful Intubation Rate
Time frame: From intervention administration until 5 minutes after intubation.
Successful placement of an endotracheal tube without the need for rescue airway anesthesia.
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Procedure-Related Complications
Time frame: From intervention administration until 5 minutes after intubation.
Incidence of adverse events including airway trauma, desaturation, allergic reactions, hoarseness, or other procedure-related complications.
Study contacts
Contact information is provided by the study sponsor or research team.
Aniqa Intizar
CONTACT
Ijaz Khalid
CONTACT
Sponsors and collaborators
Lead sponsor
Mayo Hospital Lahore
Other
Registry information
Official study title
COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION, A RANDOMIZED CONTROLLED TRIAL
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 4, 2026
- Registry last updated
- Jun 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.