ClinicalTrials.gg
Active, not recruitingNCT07832214Updated Sep 21, 2026

Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patient.

An interventional study of · 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 Cough Suppression and Thyroidectomy, sponsored by Sohag University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Sohag University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Cough Suppression
  • Thyroidectomy

Browse trials for

03

In context

Cough

427 studies on the registry are indexed under Cough; 67 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 319 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients aged 18-65 years

    • (ASA) physical status I-II
    • Scheduled for elective thyroidectomy under general anesthesia with endotracheal intubation
    • Provided written

Exclusion criteria

Exclusion Criteria:

  • Known allergy or 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, )
    • 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
    • Anticipated difficult airway (Mallampati class III-IV, limited neck extension)
    • Preoperative use of antitussive medications or opioids
    • >35 kg/m²
    • Emergency surgery
    • Participation in another interventional trial within 30 days
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Dex-Lido Group (n=40)

    Received topical spray containing dexmedetomidine 1 μg/kg combined with 2% lidocaine (total volume 5 mL)

    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

  • Active comparator
    Lido Group (n=40)

    Received topical spray containing 2% lidocaine alone (5 mL)

    Drug: · Lido solution: 2% lidocaine, 5 mL

  • Placebo comparator
    Control Group (n=40)

    Received topical spray containing 0.9% normal saline (5 mL)

    Drug: · Control solution: 0.9% normal saline, 5 mL

Interventions

  • 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

    * 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· 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· 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 minutes following complete tube extubation

Secondary outcomes

  1. 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)

    Time frame: 10 minutes post extubations

  2. 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

    Time frame: at 1, 6, 24, and 48 hours postoperatively

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832214
Lead sponsor
Sohag University
Responsible party
Islam Mokhtar Ahmed (Assistant professor, Sohag University) — Principal investigator
First posted
Sep 21, 2026
Start date
Jul 1, 2026
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion