Airway Complication of AnesthesiaNCT07916246
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
A study testing Dexmedetomidine and Alkalinized Lidocaine in people with Airway Complication of Anesthesia and Hemodynamic Instability, run by Beni-Suef University at 1 site in Egypt.
Trial summary
BACKGROUND \& PURPOSE: Elderly patients undergoing surgery under general anesthesia are at higher risk for complications when the breathing tube (endotracheal tube) is removed at the end of surgery. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Airway Complication of Anesthesia, Hemodynamic Instability, Postoperative Complications
- What is being tested?
- Dexmedetomidine and Alkalinized Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 to 85 years (inclusive).
- American Society of Anesthesiologists (ASA) physical status II or III.
- Scheduled for elective non-cardiac surgery under general anesthesia requiring oral endotracheal tube placement (e.g., abdominal, urologic, orthopedic, gynecologic procedures).
- Expected surgical/anesthesia duration between 60 and 240 minutes.
- Patient positioned in the supine position during surgery.
- Anticipated postoperative extubation in the operating room.
- Ability of the patient to provide written informed consent.
Who cannot join
- Known hypersensitivity, allergy, or contraindication to lidocaine, dexmedetomidine, amide local anesthetics, or sodium bicarbonate.
- Anticipated difficult airway/intubation, requirement for rapid-sequence induction (RSI), or high aspiration risk.
- Pre-existing significant upper airway pathology (e.g., vocal cord paralysis, subglottic stenosis) or acute upper respiratory tract infection within 2 weeks prior to surgery.
- History of chronic cough, severe chronic obstructive pulmonary disease (COPD), or uncontrolled asthma.
- Pre-existing cardiac conduction defects (e.g., second- or third-degree atrioventricular block without a functioning pacemaker), resting bradycardia (heart rate <50 beats/min), or uncontrolled baseline hypotension (systolic blood pressure <90 mmHg).
- Significant hepatic impairment (Child-Pugh Class C) or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²).
- Cognitive impairment or severe dementia precluding valid written informed consent or reliable postoperative outcome evaluation.
- Planned postoperative mechanical ventilation, delayed extubation, or planned immediate ICU admission.
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: Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Reducing Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients: A Randomized Double-Blind Controlled Trial
BACKGROUND \& PURPOSE:
Elderly patients undergoing surgery under general anesthesia are at higher risk for complications when the breathing tube (endotracheal tube) is removed at the end of surgery. Strong coughing or straining during tube removal can cause sudden surges in heart rate and blood pressure, which can lead to complications in older adults with heart or blood vessel conditions.
Read more
This study compares two medications placed directly inside the balloon (cuff) of the breathing tube to see which one better prevents coughing and stabilizes blood pressure during tube removal.
WHO CAN PARTICIPATE:
Patients aged 65 to 85 years old who are scheduled for elective non-cardiac surgery under general anesthesia requiring a breathing tube.
STUDY GROUPS \& PROCEDURES:
Participants will be randomly assigned (like flipping a coin) to one of two groups:
- Group DEX: The breathing tube balloon will be filled with a liquid solution containing dexmedetomidine (a medication that calms breathing airway responses and stabilizes heart rate).
- Group LIDO: The breathing tube balloon will be filled with alkalinized lidocaine (a numbing medication combined with sodium bicarbonate to help it pass through the tube balloon).
Both medications are designed to seep slowly through the balloon membrane to numb and soothe the airway without entering the bloodstream in large amounts. Neither the patient, the operating room team, nor the researchers evaluating recovery will know which medication is in the tube balloon during surgery.
EXPECTED OUTCOMES:
The primary goal is to measure how many patients experience a "smooth extubation" (defined as having no cough or only a single mild cough) during the first 60 seconds after the breathing tube is removed.
Researchers will also measure blood pressure and heart rate changes before and after tube removal, evaluate recovery quality, and track throat comfort (sore throat or hoarseness) at 1, 6, 12, and 24 hours after surgery.
Read the detailed description
RATIONALE \& BACKGROUND:
Coughing and bucking during emergence from general anesthesia increase intracranial, intraocular, and intra-abdominal pressures, compromising surgical repairs and precipitating cardiovascular events. Intracuff alkalinized lidocaine allows local anesthetic to diffuse passively through the semipermeable ETT cuff membrane into the tracheal mucosa, providing topical analgesia. However, clinical trials and meta-analyses demonstrate variable efficacy for intracuff lidocaine, with some trials showing limited effect at extubation.
Dexmedetomidine, a highly selective alpha-2 adrenoceptor agonist, possesses potent sedative, sympatholytic, and analgesic properties. Non-intravenous routes (intratracheal/nebulized) have demonstrated local airway attenuation of cough and sore throat with minimal systemic exposure. Dexmedetomidine's physicochemical properties (molecular weight 236.7 Da, log P ~2.8, non-ionized at physiological pH) favor transcellular diffusion across polymer cuff membranes.
HYPOTHESIS:
Intracuff dexmedetomidine will achieve a higher proportion of smooth extubations and provide superior hemodynamic stability compared to intracuff alkalinized lidocaine in elderly patients.
METHODOLOGY \& PROCEDURES:
Elderly patients (65-85 years, ASA physical status II-III) undergoing elective non-cardiac surgery under general anesthesia with tracheal intubation (expected duration 60-240 minutes) will be enrolled.
Standard high-volume, low-pressure PVC cuffed ETTs will be used. Following successful intubation, ETT cuffs will be inflated with either:
- Group DEX: Dexmedetomidine 16 µg diluted in normal saline (4 mL total volume, concentration 4 µg/mL).
- Group LIDO: 2 mL 2% lidocaine (40 mg) mixed with 2 mL 8.4% sodium bicarbonate (4 mL total volume).
Cuff pressure will be monitored and maintained at 20-25 cmH2O throughout surgery. Anesthesia management, intraoperative analgesia, and neuromuscular blockade reversal (neostigmine/glycopyrrolate) will be strictly standardized.
ASSESSMENTS:
At the conclusion of surgery, extubation will proceed once standardized extubation criteria are fulfilled. A blinded observer will assess cough severity on a validated 4-point scale during the first 60 seconds following ETT passage through the vocal cords. Hemodynamic variables (HR and MAP) will be recorded at baseline, pre-extubation, and at 1, 3, 5, and 10 minutes post-extubation. Postoperative sore throat and hoarseness will be evaluated at 1, 6, 12, and 24 hours post-extubation.
- Conditions
- Airway Complication of Anesthesia, Hemodynamic Instability, Postoperative Complications, Emergence Delirium, Anesthesia
- Being tested
- Dexmedetomidine, Alkalinized Lidocaine
- Keywords
- Intracuff administration, Dexmedetomidine, Airway extubation, Alkalinized lidocaine, Peri-extubation cough, Hemodynamic response, Postoperative sore throat, Elderly patients, Smooth extubation
- Medical subject headings
- Postoperative Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex, Intracuff Dexmedetomidine
Formulation: Dexmedetomidine hydrochloride concentrate diluted in 0.9% normal saline to a final concentration of 4 µg/mL.
Dose: 16 µg total dose delivered in a total volume of 4 mL. Route: Intracuff (instilled directly into the high-volume, low-pressure PVC endotracheal tube cuff).
Timing \& Duration: Instilled immediately post-intubation and maintained in the cuff throughout the surgical procedure (duration 60-240 minutes).
Pressure Control: Cuff pressure monitored with a calibrated manometer immediately after intubation and every 30 minutes to maintain 20-25 cmH2O (volume adjusted by ±1 mL saline if needed).
Alkalinized LidocaineDrug
Also called Lignocaine with Sodium Bicarbonate, Intracuff Lidocaine
Formulation: 2 mL of 2% preservative-free lidocaine hydrochloride (40 mg) mixed with 2 mL of 8.4% sodium bicarbonate (total volume 4 mL), creating an alkalinized local anesthetic mixture (pH ~7.4-8.0).
Dose: 40 mg lidocaine hydrochloride with sodium bicarbonate. Route: Intracuff (instilled directly into the high-volume, low-pressure PVC endotracheal tube cuff).
Timing \& Duration: Instilled immediately post-intubation and maintained in the cuff throughout the surgical procedure (duration 60-240 minutes).
Pressure Control: Cuff pressure monitored with a calibrated manometer immediately after intubation and every 30 minutes to maintain 20-25 cmH2O (volume adjusted by ±1 mL saline if needed).
| Study group | Role | What they receive |
|---|---|---|
| Group DEX (Intracuff Dexmedetomidine) | Experimental | Elderly surgical patients whose endotracheal tube (ETT) cuff is filled with a dexmedetomidine solution (16 µg total dose in 4 mL normal saline) immediately following tracheal intubation. Cuff pressure is maintained at 20-25 cmH2O throughout the surgery. Receives: Drug: Dexmedetomidine |
| Group LIDO (Intracuff Alkalinized Lidocaine) | Active comparator | Elderly surgical patients whose endotracheal tube (ETT) cuff is filled with an alkalinized lidocaine solution (40 mg lidocaine + 8.4% sodium bicarbonate, total volume 4 mL) immediately following tracheal intubation. Cuff pressure is maintained at 20-25 cmH2O throughout the surgery. Receives: Drug: Alkalinized Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Smooth Extubation
Proportion (percentage) of participants in each group achieving smooth extubation, defined as a cough score of 0 or 1 on a validated 4-point scale during the first 60 seconds after tube removal. Assessment begins continuously at the exact moment the endotracheal tube cuff passes through the vocal cords (marked by stopwatch).
Cough Scale:
- 0 = No cough
- 1 = Single mild cough
- 2 = Moderate coughing (2-3 coughs)
- 3 = Severe coughing (≥4 coughs or bucking)
A score of 0-1 indicates smooth extubation (desirable outcome).
Measured: During the first 60 seconds post-extubation
Secondary outcomes (8)
Peri-Extubation Cough Severity Score
Distribution and median score of peri-extubation cough severity evaluated on the 4-point ordinal scale (0 = No cough, 1 = Single mild cough, 2 = Moderate coughing [2-3 coughs], 3 = Severe coughing [≥4 coughs or bucking]). Lower scores indicate better outcomes.
Measured: During the first 60 seconds post-extubation
Maximum Percentage Change in Mean Arterial Pressure (MAP) and Heart Rate (HR)
Maximum absolute and percentage change from baseline in MAP (mmHg) and HR (beats/min). Pre-induction baseline is defined as the mean of three resting readings at 2-minute intervals. Additionally, the proportion of participants experiencing a clinically significant hemodynamic response (defined as MAP or HR increase >20% above baseline sustained for ≥2 consecutive readings) will be reported.
Measured: From 1 minute before extubation up to 10 minutes post-extubation
Incidence and Severity of Postoperative Sore Throat (POST)
Incidence and severity of POST assessed on a 4-point scale: 0 = None (no sore throat), 1 = Mild (discomfort with swallowing), 2 = Moderate (constant discomfort, worse with swallowing), 3 = Severe (severe pain interfering with eating/speaking). Lower scores indicate less airway morbidity.
Measured: At 1, 6, 12, and 24 hours post-extubation
Incidence and Severity of Postoperative Hoarseness
Incidence and severity of hoarseness assessed on a 4-point scale: 0 = None (normal voice), 1 = Mild (noticed only by patient), 2 = Moderate (noticeable voice change to observer), 3 = Severe (aphonia or severe hoarseness). Lower scores indicate less vocal cord dysfunction.
Measured: At 1, 6, 12, and 24 hours post-extubation
Emergence Times and Time to PACU Recovery
Time intervals (in minutes) measured from discontinuation of volatile anesthetic (sevoflurane) to: (1) Eye opening, (2) Following verbal commands, (3) Tracheal extubation, and (4) Time to achieve an Aldrete recovery score ≥9 in the PACU.
Measured: From anesthetic discontinuation up to 120 minutes postoperatively
Richmond Agitation-Sedation Scale (RASS) Score
Emergence agitation or sedation evaluated using the Richmond Agitation-Sedation Scale (RASS), ranging from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm.
Measured: At 1, 3, 5, and 10 minutes post-extubation
Incidence of Perioperative Adverse Events and Hemodynamic Complications
Proportion of participants experiencing safety events: bradycardia (HR <50 bpm or requiring atropine), hypotension (MAP <65 mmHg or >30% drop from baseline requiring vasopressors), hypoxemia (SpO2 <92%), arrhythmias, bronchospasm, laryngospasm, reintubation, unexpected ICU admission, and in-hospital mortality.
Measured: Through 24 hours postoperatively
Composite Smooth Extubation Rate [Exploratory Endpoint]
Proportion of participants meeting all three composite criteria simultaneously: (1) Cough score 0-1 during first 60 s post-extubation AND (2) Maximum MAP and HR change ≤20% from baseline AND (3) Absence of severe agitation (RASS ≤+2). Retained for contextual comparison with legacy literature.
Measured: During the first 10 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Moneer Neseem Mikhael, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916246
- Sponsor's protocol ID
- FMBSUREC/07062026a/ Mikhael
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary results (including demographic data, cough scores, hemodynamic measurements, emergence characteristics, and adverse events) will be made available upon reasonable request to qualified academic researchers following publication of the primary study findings.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Reducing Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07916246
- Acronym / sponsor ID
- FMBSUREC/07062026a/ Mikhael
- Conditions
- Airway Complication of Anesthesia, Hemodynamic Instability, Postoperative Complications, Emergence Delirium, Anesthesia
- Keywords
- Intracuff administration, Dexmedetomidine, Airway extubation, Alkalinized lidocaine, Peri-extubation cough, Hemodynamic response, Postoperative sore throat, Elderly patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Nov 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.
BACKGROUND \& PURPOSE:
Elderly patients undergoing surgery under general anesthesia are at higher risk for complications when the breathing tube (endotracheal tube) is removed at the end of surgery. Strong coughing or straining during tube removal can cause sudden surges in heart rate and blood pressure, which can lead to complications in older adults with heart or blood vessel conditions.
This study compares two medications placed directly inside the balloon (cuff) of the breathing tube to see which one better prevents coughing and stabilizes blood pressure during tube removal.
WHO CAN PARTICIPATE:
Patients aged 65 to 85 years old who are scheduled for elective non-cardiac surgery under general anesthesia requiring a breathing tube.
STUDY GROUPS \& PROCEDURES:
Participants will be randomly assigned (like flipping a coin) to one of two groups:
- Group DEX: The breathing tube balloon will be filled with a liquid solution containing dexmedetomidine (a medication that calms breathing airway responses and stabilizes heart rate).
- Group LIDO: The breathing tube balloon will be filled with alkalinized lidocaine (a numbing medication combined with sodium bicarbonate to help it pass through the tube balloon).
Both medications are designed to seep slowly through the balloon membrane to numb and soothe the airway without entering the bloodstream in large amounts. Neither the patient, the operating room team, nor the researchers evaluating recovery will know which medication is in the tube balloon during surgery.
EXPECTED OUTCOMES:
The primary goal is to measure how many patients experience a "smooth extubation" (defined as having no cough or only a single mild cough) during the first 60 seconds after the breathing tube is removed.
Researchers will also measure blood pressure and heart rate changes before and after tube removal, evaluate recovery quality, and track throat comfort (sore throat or hoarseness) at 1, 6, 12, and 24 hours after surgery.
Detailed description
RATIONALE \& BACKGROUND:
Coughing and bucking during emergence from general anesthesia increase intracranial, intraocular, and intra-abdominal pressures, compromising surgical repairs and precipitating cardiovascular events. Intracuff alkalinized lidocaine allows local anesthetic to diffuse passively through the semipermeable ETT cuff membrane into the tracheal mucosa, providing topical analgesia. However, clinical trials and meta-analyses demonstrate variable efficacy for intracuff lidocaine, with some trials showing limited effect at extubation.
Dexmedetomidine, a highly selective alpha-2 adrenoceptor agonist, possesses potent sedative, sympatholytic, and analgesic properties. Non-intravenous routes (intratracheal/nebulized) have demonstrated local airway attenuation of cough and sore throat with minimal systemic exposure. Dexmedetomidine's physicochemical properties (molecular weight 236.7 Da, log P ~2.8, non-ionized at physiological pH) favor transcellular diffusion across polymer cuff membranes.
HYPOTHESIS:
Intracuff dexmedetomidine will achieve a higher proportion of smooth extubations and provide superior hemodynamic stability compared to intracuff alkalinized lidocaine in elderly patients.
METHODOLOGY \& PROCEDURES:
Elderly patients (65-85 years, ASA physical status II-III) undergoing elective non-cardiac surgery under general anesthesia with tracheal intubation (expected duration 60-240 minutes) will be enrolled.
Standard high-volume, low-pressure PVC cuffed ETTs will be used. Following successful intubation, ETT cuffs will be inflated with either:
- Group DEX: Dexmedetomidine 16 µg diluted in normal saline (4 mL total volume, concentration 4 µg/mL).
- Group LIDO: 2 mL 2% lidocaine (40 mg) mixed with 2 mL 8.4% sodium bicarbonate (4 mL total volume).
Cuff pressure will be monitored and maintained at 20-25 cmH2O throughout surgery. Anesthesia management, intraoperative analgesia, and neuromuscular blockade reversal (neostigmine/glycopyrrolate) will be strictly standardized.
ASSESSMENTS:
At the conclusion of surgery, extubation will proceed once standardized extubation criteria are fulfilled. A blinded observer will assess cough severity on a validated 4-point scale during the first 60 seconds following ETT passage through the vocal cords. Hemodynamic variables (HR and MAP) will be recorded at baseline, pre-extubation, and at 1, 3, 5, and 10 minutes post-extubation. Postoperative sore throat and hoarseness will be evaluated at 1, 6, 12, and 24 hours post-extubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DEX (Intracuff Dexmedetomidine) | Experimental | Drug: DexmedetomidineElderly surgical patients whose endotracheal tube (ETT) cuff is filled with a dexmedetomidine solution (16 µg total dose in 4 mL normal saline) immediately following tracheal intubation. Cuff pressure is maintained at 20-25 cmH2O throughout the surgery. |
| Group LIDO (Intracuff Alkalinized Lidocaine) | Active comparator | Drug: Alkalinized LidocaineElderly surgical patients whose endotracheal tube (ETT) cuff is filled with an alkalinized lidocaine solution (40 mg lidocaine + 8.4% sodium bicarbonate, total volume 4 mL) immediately following tracheal intubation. Cuff pressure is maintained at 20-25 cmH2O throughout the surgery. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 to 85 years (inclusive).
- American Society of Anesthesiologists (ASA) physical status II or III.
- Scheduled for elective non-cardiac surgery under general anesthesia requiring oral endotracheal tube placement (e.g., abdominal, urologic, orthopedic, gynecologic procedures).
- Expected surgical/anesthesia duration between 60 and 240 minutes.
- Patient positioned in the supine position during surgery.
Key exclusion criteria (8 listed)
- Known hypersensitivity, allergy, or contraindication to lidocaine, dexmedetomidine, amide local anesthetics, or sodium bicarbonate.
- Anticipated difficult airway/intubation, requirement for rapid-sequence induction (RSI), or high aspiration risk.
- Pre-existing significant upper airway pathology (e.g., vocal cord paralysis, subglottic stenosis) or acute upper respiratory tract infection within 2 weeks prior to surgery.
- History of chronic cough, severe chronic obstructive pulmonary disease (COPD), or uncontrolled asthma.
- Pre-existing cardiac conduction defects (e.g., second- or third-degree atrioventricular block without a functioning pacemaker), resting bradycardia (heart rate <50 beats/min), or uncontrolled baseline hypotension (systolic blood pressure <90 mmHg).
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex, Intracuff DexmedetomidineFormulation: Dexmedetomidine hydrochloride concentrate diluted in 0.9% normal saline to a final concentration of 4 µg/mL. Dose: 16 µg total dose delivered in a total volume of 4 mL. Route: Intracuff (instilled directly into the high-volume, low-pressure PVC endotracheal tube cuff). Timing \& Duration: Instilled immediately post-intubation and maintained in the cuff throughout the surgical procedure (duration 60-240 minutes). Pressure Control: Cuff pressure monitored with a calibrated manometer immediately after intubation and every 30 minutes to maintain 20-25 cmH2O (volume adjusted by ±1 mL saline if needed). | Drug | Group DEX (Intracuff Dexmedetomidine) |
| Alkalinized LidocaineAlso: Lignocaine with Sodium Bicarbonate, Intracuff LidocaineFormulation: 2 mL of 2% preservative-free lidocaine hydrochloride (40 mg) mixed with 2 mL of 8.4% sodium bicarbonate (total volume 4 mL), creating an alkalinized local anesthetic mixture (pH ~7.4-8.0). Dose: 40 mg lidocaine hydrochloride with sodium bicarbonate. Route: Intracuff (instilled directly into the high-volume, low-pressure PVC endotracheal tube cuff). Timing \& Duration: Instilled immediately post-intubation and maintained in the cuff throughout the surgical procedure (duration 60-240 minutes). Pressure Control: Cuff pressure monitored with a calibrated manometer immediately after intubation and every 30 minutes to maintain 20-25 cmH2O (volume adjusted by ±1 mL saline if needed). | Drug | Group LIDO (Intracuff Alkalinized Lidocaine) |
Primary outcome
Incidence of Smooth Extubation
Time frame: During the first 60 seconds post-extubation
Proportion (percentage) of participants in each group achieving smooth extubation, defined as a cough score of 0 or 1 on a validated 4-point scale during the first 60 seconds after tube removal. Assessment begins continuously at the exact moment the endotracheal tube cuff passes through the vocal cords (marked by stopwatch). Cough Scale: * 0 = No cough * 1 = Single mild cough * 2 = Moderate coughing (2-3 coughs) * 3 = Severe coughing (≥4 coughs or bucking) A score of 0-1 indicates smooth extubation (desirable outcome).
8 secondary outcomes
Peri-Extubation Cough Severity Score
Time frame: During the first 60 seconds post-extubation
Maximum Percentage Change in Mean Arterial Pressure (MAP) and Heart Rate (HR)
Time frame: From 1 minute before extubation up to 10 minutes post-extubation
Incidence and Severity of Postoperative Sore Throat (POST)
Time frame: At 1, 6, 12, and 24 hours post-extubation
Incidence and Severity of Postoperative Hoarseness
Time frame: At 1, 6, 12, and 24 hours post-extubation
Emergence Times and Time to PACU Recovery
Time frame: From anesthetic discontinuation up to 120 minutes postoperatively
Richmond Agitation-Sedation Scale (RASS) Score
Time frame: At 1, 3, 5, and 10 minutes post-extubation
Incidence of Perioperative Adverse Events and Hemodynamic Complications
Time frame: Through 24 hours postoperatively
Composite Smooth Extubation Rate [Exploratory Endpoint]
Time frame: During the first 10 minutes post-extubation
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 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary results (including demographic data, cough scores, hemodynamic measurements, emergence characteristics, and adverse events) will be made available upon reasonable request to qualified academic researchers following publication of the primary study findings.
Related trials for Airway Complication of Anesthesia
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Extubation Failures, Extubation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Alkalinized Lidocaine in people with Airway Complication of Anesthesia and Hemodynamic Instability, run by Beni-Suef University at 1 site in Egypt.
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 7 inclusion and 8 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 Nov 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 Egypt. 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 Kerollos Moneer Neseem Mikhael, MD (00201288549959, Kmnmk87@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Smooth Extubation (time frame: During the first 60 seconds post-extubation). 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 Nov 2026.