An interventional study of Dexmedetomidine and Alkalinized Lidocaine in Airway Complication of Anesthesia, Hemodynamic Instability and Postoperative Complications, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Prevention
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:
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.
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:
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.
795 studies on the registry are indexed under Emergence Delirium; 257 are open to participants now.
This study's planned enrollment of 184 is above the median of 120 across 496 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Beni-Suef University is the lead sponsor of 341 studies on the registry; 118 are open to participants now.
Compared within Emergence Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Drug: Dexmedetomidine
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.
Drug: Alkalinized Lidocaine
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).
Also known as: Precedex, Intracuff Dexmedetomidine
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).
Also known as: Lignocaine with Sodium Bicarbonate, Intracuff Lidocaine
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).
Time frame: During the first 60 seconds post-extubation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the first 10 minutes post-extubation
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available beginning 6 months following primary journal publication and will remain available for up to 3 years.
Access criteria: Data will be shared with researchers who provide a scientifically sound proposal and obtain formal data access approval from the principal investigator and the Research Ethical Committee, Faculty of Medicine, Beni-Suef University. Data transfer agreement must be signed prior to access.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dexmedetomidine