Cough SuppressionNCT07832214
Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patient.
A study testing · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume and · Lido solution: 2% lidocaine, 5 mL in people with Cough Suppression and Thyroidectomy, run by Sohag University at 1 site in Egypt.
Trial summary
Study Hypothesis: The combination of dexmedetomidine and lidocaine administered as laryngopharyngeal topical spray provides superior suppression of extubation cough reflex compared to lidocaine alone or placebo, without compromising recovery or increasing adverse events Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cough Suppression, Thyroidectomy
- What is being tested?
- · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume and · Lido solution: 2% lidocaine, 5 mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Dec 2026
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective thyroidectomy under general anesthesia with endotracheal intubation
- Provided written informed consent
Who cannot join
- Known allergy or contraindication to dexmedetomidine, lidocaine, or study medications
- Pre-existing cough or respiratory tract infection within 2 weeks
- History of chronic cough or reactive airway disease (asthma, COPD)
- Significant cardiovascular disease (arrhythmias, uncontrolled hypertension, heart failure)
- Hepatic or renal dysfunction (liver enzymes >2× upper normal limit, creatinine >1.5 mg/dL)
- Pregnancy or breastfeeding
Show all 11Show fewer
- Anticipated difficult airway (Mallampati class III-IV, limited neck extension)
- Preoperative use of antitussive medications or opioids
- Body mass index >35 kg/m²
- Emergency surgery
- Participation in another interventional trial within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patients : A Randomized Clinical Trial
Study Hypothesis: The combination of dexmedetomidine and lidocaine administered as laryngopharyngeal topical spray provides superior suppression of extubation cough reflex compared to lidocaine alone or placebo, without compromising recovery or increasing adverse events
- Conditions
- Cough Suppression, Thyroidectomy
- Being tested
- · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume, · Lido solution: 2% lidocaine, 5 mL, · Control solution: 0.9% normal saline, 5 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
· Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volumeDrug
- Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume
- Lido solution: 2% lidocaine, 5 mL
- Control solution: 0.9% normal saline, 5 mL
All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray.
· Lido solution: 2% lidocaine, 5 mLDrug
- Lido solution: 2% lidocaine, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray.
· Control solution: 0.9% normal saline, 5 mLDrug
- Control solution: 0.9% normal saline, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray.
| Study group | Role | What they receive |
|---|---|---|
| Dex-Lido Group (n=40) | Experimental | Received topical spray containing dexmedetomidine 1 μg/kg combined with 2% lidocaine (total volume 5 mL) Receives: Drug: · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume |
| Lido Group (n=40) | Active comparator | Received topical spray containing 2% lidocaine alone (5 mL) Receives: Drug: · Lido solution: 2% lidocaine, 5 mL |
| Control Group (n=40) | Placebo comparator | Received topical spray containing 0.9% normal saline (5 mL) Receives: Drug: · Control solution: 0.9% normal saline, 5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cough reflex during extubation
any visible or audible cough occurring from the time of endotracheal tube cuff deflation until 2 minutes following complete tube removal.
Measured: 2 minutes following complete tube extubation
Secondary outcomes (2)
Cough Severity
Graded on a 4-point scale]:
- Grade 0: No cough
- Grade 1: Single cough (mild)
- Grade 2: Multiple coughs lasting <5 seconds (moderate)
- Grade 3: Sustained coughing >5 seconds or severe paroxysms (severe)
Measured: 10 minutes post extubations
Postoperative Sore Throat
using a 0-10 numerical rating scale (0 = no sore throat, 10 = worst imaginable sore throat)
- Incidence of moderate-to-severe sore throat (score ≥4
Measured: at 1, 6, 24, and 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough SuppressionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832214
- Sponsor's protocol ID
- Soh-Med-26-6-15PD
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patients : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07832214
- Acronym / sponsor ID
- Soh-Med-26-6-15PD
- Conditions
- Cough Suppression, Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 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.
Study Hypothesis: The combination of dexmedetomidine and lidocaine administered as laryngopharyngeal topical spray provides superior suppression of extubation cough reflex compared to lidocaine alone or placebo, without compromising recovery or increasing adverse events
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dex-Lido Group (n=40) | Experimental | Drug: · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volumeReceived topical spray containing dexmedetomidine 1 μg/kg combined with 2% lidocaine (total volume 5 mL) |
| Lido Group (n=40) | Active comparator | Drug: · Lido solution: 2% lidocaine, 5 mLReceived topical spray containing 2% lidocaine alone (5 mL) |
| Control Group (n=40) | Placebo comparator | Drug: · Control solution: 0.9% normal saline, 5 mLReceived topical spray containing 0.9% normal saline (5 mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18-65 years
Key exclusion criteria (11 listed)
- Known allergy or contraindication to dexmedetomidine, lidocaine, or study medications
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 |
|---|---|---|
| · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume* Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume * Lido solution: 2% lidocaine, 5 mL * Control solution: 0.9% normal saline, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray. | Drug | Dex-Lido Group (n=40) |
| · Lido solution: 2% lidocaine, 5 mL· Lido solution: 2% lidocaine, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray. | Drug | Lido Group (n=40) |
| · Control solution: 0.9% normal saline, 5 mL· Control solution: 0.9% normal saline, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray. | Drug | Control Group (n=40) |
Primary outcome
Incidence of cough reflex during extubation
Time frame: 2 minutes following complete tube extubation
any visible or audible cough occurring from the time of endotracheal tube cuff deflation until 2 minutes following complete tube removal.
2 secondary outcomes
Cough Severity
Time frame: 10 minutes post extubations
Postoperative Sore Throat
Time frame: at 1, 6, 24, and 48 hours postoperatively
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 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume and · Lido solution: 2% lidocaine, 5 mL in people with Cough Suppression and Thyroidectomy, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cough reflex during extubation (time frame: 2 minutes following complete tube 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 21 Sep 2026.