Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dexmedetomidine Lidocaine Saline.
- Who it may be relevant to
- Registry conditions: FESS Operation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Functional Endoscopic Sinus Surgery and Nasal Reconstruction (Prospective, Randomized, Controlled Clinical Study).
Overview
compare the efficacy of intratracheal dexmedetomidine versus intratracheal lidocaine in achieving smooth tracheal extubation in patients undergoing Functional Endoscopic Sinus surgery and reconstructive nasal surgeries under general anesthesia.
Detailed description
undergoing Functional Endoscopic Sinus Surgery (FESS). Emergence from anesthesia and extubation are often associated with undesirable airway reflexes such as coughing, bucking, laryngospasm, and marked hemodynamic fluctuations, which may adversely affect surgical outcomes and increase postoperative morbidity .
Hemodynamic instability during extubation may result in complications such as bleeding at the surgical site, myocardial ischemia, arrhythmias, and increased intracranial and intraocular pressure . These responses are particularly hazardous in FESS, where a bloodless surgical field is essential for optimal visualization and surgical success .
Several pharmacological agents has been studied to attenuate these responses, including opioids, beta blockers, local anesthetics, and α₂-adrenergic agonists . Lidocaine is commonly used to suppress airway reflexes during extubation, either intravenously or intratracheally, due to its local anesthetic effect on airway mucosa; however, its efficacy may be short-lived .
Dexmedetomidine is a highly selective α₂-adrenergic agonist that provides sedation, analgesia, and sympatholysis with minimal respiratory depression. It has been shown to attenuate stress responses during emergence and extubation more effectively than many traditional agents . Intratracheal administration of dexmedetomidine allows rapid absorption through the pulmonary circulation, leading to effective suppression of cough and hemodynamic responses .
Interventions
- Drug dexmedetomidine Lidocaine Saline
At the end of the surgery , the endotracheal tube cuff will be deflated and the study drug will be administered intratracheally. Manual positive pressure ventilation will be applied for drug distribution, followed by cuff reinflation
Primary outcome measures
- Quality of extubation assessed by cough score at extubation . scored 0-5: 0 = No cough 1 = Occasional, single cough 2 = Mild, does not interfere with activities 3 = Moderate, interferes with activities 4 = Severe 5 = very sever. 0 is better 5 is worst [Time frame: at time of extubation]
Eligibility criteria
Inclusion criteria
- \- Age 18-60 years.
- Elective FESS under general anesthesia.
- ASA Physical Status I-II
Exclusion criteria
- Allergy to dexmedetomidine or lidocaine
- Anticipated difficult airway
- Chronic pulmonary diseases (asthma, COPD)
- Uncontrolled hypertension or ischemic heart disease
- Patient refusal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07504497 · Soh-Med-26-3-7MS