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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized Lidocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to 5 minutes after intubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | Time from insertion of the fiberoptic bronchoscope until confirmation of successful endotracheal tube placement. | During the intubation procedure. |
| Patient Comfort Score | Patient comfort assessed using a standardized 5-point tolerance scale. |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aniqa Intizar | Contact | +923349872530 | aniqaintizar1040@gmail.com | |
| Ijaz Khalid | Contact | +923008579196 | ejazrao@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Aniqa Intizar | Mayo Hospital Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| Nerve Block | Procedure | 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. |
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| Immediately after completion of awake fiberoptic intubation. |
| Cough Severity Score | Severity of coughing during awake fiberoptic intubation assessed using a predefined cough scoring system. | During the intubation procedure. |
| Successful Intubation Rate | Successful placement of an endotracheal tube without the need for rescue airway anesthesia. | 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. | From intervention administration until 5 minutes after intubation. |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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