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Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients

Key facts

Who runs it
Beni-Suef University
Where
Egypt1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
184 people, planned
Started
Nov 2026
Expected to end
May 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dexmedetomidine
  • Alkalinized Lidocaine
Record updated
4 November 2026

Who can take part

Age
65 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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 take part

  • 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)
  • Cognitive impairment or severe dementia precluding valid written informed consent or reliable postoperative outcome evaluation
  • Known hypersensitivity, allergy, or contraindication to lidocaine, dexmedetomidine, amide local anesthetics, or sodium bicarbonate
  • Significant hepatic impairment (Child-Pugh Class C) or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²)
  • Anticipated difficult airway/intubation, requirement for rapid-sequence induction (RSI), or high aspiration risk
  • Planned postoperative mechanical ventilation, delayed extubation, or planned immediate ICU admission

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 65 and 85 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

BACKGROUND \& PURPOSE:

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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:

1. 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). 2. 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.

The 2 groups in the trial

  • Group DEX (Intracuff Dexmedetomidine)Treatment being tested

    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.

    Treatment: Dexmedetomidine

  • Group LIDO (Intracuff Alkalinized Lidocaine)Existing treatment, for comparison

    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.

    Treatment: Alkalinized Lidocaine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Reducing Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients: A Randomized Double-Blind Controlled Trial
Fit questions
Built from NCT07916246, who can take part
Record updated
4 November 2026