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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: FESS Operation
• Intervention / Treatment: Drug: dexmedetomidine Lidocaine Saline

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 .

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: youness ahmed youness, resident doctor; Phone Number: 01121614761; Email: younessahmeh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine Group; patients receive Intratracheal dexmedetomidine 0.5 µg/kg diluted to 4 mL with normal saline	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
Active Comparator: Lidocaine Group; patients receive Intratracheal lidocaine hydrochloride 2% 1.5 mg/kg (4 mL) (6,8).	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
Placebo Comparator: Saline group; patient receive 4 mL of normal saline	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 worst	at time of extubation

Collaborators and Investigators

• Sponsor: Younes Ahmed Younes

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-26-3-7MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No