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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kerollos Moneer Neseem Mikhael, MD
- 전화번호: 00201288549959
- 이메일: Kmnmk87@med.bsu.edu.eg
연구 장소
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Banī Suwayf, 이집트
- Beni-Suef University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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).
다른 이름들:
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활성 비교기: 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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Smooth Extubation
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peri-Extubation Cough Severity Score
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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]
기간: 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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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC/07062026a/ Mikhael
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Data will become available beginning 6 months following primary journal publication and will remain available for up to 3 years.
IPD 공유 액세스 기준
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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