FESS OperationPhase 4NCT07504497
Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation
A Phase 4 study testing dexmedetomidine Lidocaine Saline in people with FESS Operation, run by Younes Ahmed Younes.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- FESS Operation
- What is being tested?
- dexmedetomidine Lidocaine Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Age 18-60 years.
- Elective FESS under general anesthesia.
- ASA Physical Status I-II
Who cannot join
- Allergy to dexmedetomidine or lidocaine
- Anticipated difficult airway
- Chronic pulmonary diseases (asthma, COPD)
- Uncontrolled hypertension or ischemic heart disease
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
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.
Read the 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 .
- Conditions
- FESS Operation
- Being tested
- dexmedetomidine Lidocaine Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine Lidocaine SalineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | patients receive Intratracheal dexmedetomidine 0.5 µg/kg diluted to 4 mL with normal saline Receives: Drug: dexmedetomidine Lidocaine Saline |
| Lidocaine Group | Active comparator | patients receive Intratracheal lidocaine hydrochloride 2% 1.5 mg/kg (4 mL) (6,8). Receives: Drug: dexmedetomidine Lidocaine Saline |
| Saline group | Placebo comparator | patient receive 4 mL of normal saline Receives: Drug: dexmedetomidine Lidocaine Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FESS OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Younes Ahmed Younes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Younes Ahmed Younes, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504497
- Sponsor's protocol ID
- Soh-Med-26-3-7MS
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT07504497
- Acronym / sponsor ID
- Soh-Med-26-3-7MS
- Conditions
- FESS Operation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Younes Ahmed YounesUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: dexmedetomidine Lidocaine Salinepatients receive Intratracheal dexmedetomidine 0.5 µg/kg diluted to 4 mL with normal saline |
| Lidocaine Group | Active comparator | Drug: dexmedetomidine Lidocaine Salinepatients receive Intratracheal lidocaine hydrochloride 2% 1.5 mg/kg (4 mL) (6,8). |
| Saline group | Placebo comparator | Drug: dexmedetomidine Lidocaine Salinepatient receive 4 mL of normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Age 18-60 years.
- Elective FESS under general anesthesia.
- ASA Physical Status I-II
Key exclusion criteria (5 listed)
- Allergy to dexmedetomidine or lidocaine
- Anticipated difficult airway
- Chronic pulmonary diseases (asthma, COPD)
- Uncontrolled hypertension or ischemic heart disease
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine Lidocaine SalineAt 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 | Drug | Dexmedetomidine Group, Lidocaine Group, Saline group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine Lidocaine Saline in people with FESS Operation, run by Younes Ahmed Younes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact youness ahmed youness, resident doctor (01121614761, younessahmeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.