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

29. oktober 2026 opdateret af: Kerollos Moneer Neseem Mikhael, Beni-Suef University

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

184

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Banī Suwayf, Egypten
        • Beni-Suef University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 85 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group DEX (Intracuff Dexmedetomidine)

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.
Medicin: 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).

Andre navne:
  • Precedex
  • Intracuff Dexmedetomidine
Aktiv komparator: Group LIDO (Intracuff Alkalinized Lidocaine)

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.
Medicin: Alkalinized 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).

Andre navne:
  • Lignocaine with Sodium Bicarbonate
  • Intracuff Lidocaine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Smooth Extubation
Tidsramme: 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).
During the first 60 seconds post-extubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peri-Extubation Cough Severity Score
Tidsramme: During the first 60 seconds post-extubation

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.
During the first 60 seconds post-extubation
Maximum Percentage Change in Mean Arterial Pressure (MAP) and Heart Rate (HR)
Tidsramme: From 1 minute before extubation up to 10 minutes post-extubation

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.
From 1 minute before extubation up to 10 minutes post-extubation
Incidence and Severity of Postoperative Sore Throat (POST)
Tidsramme: At 1, 6, 12, and 24 hours post-extubation

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.
At 1, 6, 12, and 24 hours post-extubation
Incidence and Severity of Postoperative Hoarseness
Tidsramme: At 1, 6, 12, and 24 hours post-extubation

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.
At 1, 6, 12, and 24 hours post-extubation
Emergence Times and Time to PACU Recovery
Tidsramme: From anesthetic discontinuation up to 120 minutes postoperatively

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.
From anesthetic discontinuation up to 120 minutes postoperatively
Richmond Agitation-Sedation Scale (RASS) Score
Tidsramme: At 1, 3, 5, and 10 minutes post-extubation

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.
At 1, 3, 5, and 10 minutes post-extubation
Incidence of Perioperative Adverse Events and Hemodynamic Complications
Tidsramme: Through 24 hours postoperatively

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.
Through 24 hours postoperatively
Composite Smooth Extubation Rate [Exploratory Endpoint]
Tidsramme: During the first 10 minutes post-extubation

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.
During the first 10 minutes post-extubation

Samarbejdspartnere og efterforskere

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Sponsor

Beni-Suef University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

29. oktober 2026

Først indsendt, der opfyldte QC-kriterier

29. oktober 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC/07062026a/ Mikhael

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will become available beginning 6 months following primary journal publication and will remain available for up to 3 years.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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