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Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation

Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Functional Endoscopic Sinus Surgery and Nasal Reconstruction (Prospective, Randomized, Controlled Clinical Study).

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07504497
Enrollment
120
Registered
2026-03-31
Start date
2026-04-15
Completion date
2026-12-15
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FESS Operation

Brief summary

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

DRUGdexmedetomidine 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

Sponsors

Younes Ahmed Younes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 worstat time of extubation

Contacts

CONTACTyouness ahmed youness, resident doctor
younessahmeh@gmail.com01121614761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026