Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
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:
- 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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kerollos Moneer Neseem Mikhael, MD
- 電話番号：00201288549959
- メール：Kmnmk87@med.bsu.edu.eg
研究場所
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Banī Suwayf、エジプト
- Beni-Suef University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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. |
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).
他の名前：
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アクティブコンパレータ：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. |
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).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Smooth Extubation
時間枠：During the first 60 seconds post-extubation
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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:
A score of 0-1 indicates smooth extubation (desirable outcome). |
During the first 60 seconds post-extubation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Peri-Extubation Cough Severity Score
時間枠：During the first 60 seconds post-extubation
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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
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Maximum Percentage Change in Mean Arterial Pressure (MAP) and Heart Rate (HR)
時間枠：From 1 minute before extubation up to 10 minutes post-extubation
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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
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Incidence and Severity of Postoperative Sore Throat (POST)
時間枠：At 1, 6, 12, and 24 hours post-extubation
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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
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Incidence and Severity of Postoperative Hoarseness
時間枠：At 1, 6, 12, and 24 hours post-extubation
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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
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Emergence Times and Time to PACU Recovery
時間枠：From anesthetic discontinuation up to 120 minutes postoperatively
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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
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Richmond Agitation-Sedation Scale (RASS) Score
時間枠：At 1, 3, 5, and 10 minutes post-extubation
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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
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Incidence of Perioperative Adverse Events and Hemodynamic Complications
時間枠：Through 24 hours postoperatively
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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
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Composite Smooth Extubation Rate [Exploratory Endpoint]
時間枠：During the first 10 minutes post-extubation
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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
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主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC/07062026a/ Mikhael
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will become available beginning 6 months following primary journal publication and will remain available for up to 3 years.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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