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Cough SuppressionPhase 3NCT07213037

Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery

A Phase 3 study testing Dexmedetomidine, Magnesium sulfate and lidocaine in people with Cough Suppression, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Functional Endoscopic Sinus Surgery (FESS) is a widely performed procedure for the management of chronic rhinosinusitis and nasal polyposis. Despite being minimally invasive(1).Postoperative coughing, in particular, is a frequent complication that can increase venous pressure, disrupt the surgical site, cause… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cough Suppression
What is being tested?
Dexmedetomidine, Magnesium sulfate and lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
No sites listed yet
Study dates
1 Nov 2025to 1 Dec 2026
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a. Age >18 < 60 years old b. Both genders. c. Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

Who cannot join

  • . Active airway infection
  • History of tracheal and laryngeal surgery.
  • Airway tumors,
  • Body mass index more than 35.
  • Increased intracranial and intraocular pressure.
  • Uncontrolled pulmonary diseases (bronchial asthma, chronic obstructive pulmonary disease (COPD), restrictive lung diseases).
  • Patients with a known allergy or sensitivity to any study drugs.
  • Patients' refusal to enroll in the study.

About this study

Functional Endoscopic Sinus Surgery (FESS) is a widely performed procedure for the management of chronic rhinosinusitis and nasal polyposis. Despite being minimally invasive(1).Postoperative coughing, in particular, is a frequent complication that can increase venous pressure, disrupt the surgical site, cause bleeding, and prolong recovery(2).

Coughing and other airway reflexes during extubation are largely mediated by the stimulation of rapidly adapting stretch receptors (RARs) in the trachea, often aggravated by the presence of an endotracheal tube(3). Although these reflexes are suppressed under deep anesthesia, they become prominent as the patient regains consciousness. A smooth and controlled emergence from anesthesia is especially important in sinonasal procedures where postoperative bleeding can have serious consequences(4).

Read more

Postoperative sore throat (POST) is considered a minor complication of general anesthesia. POST complaints can range in severity from slight throat irritation to incapacitating discomfort that prevents swallowing, and transitory voice alterations are frequently noticed during the postoperative visit. The identified risk factors for POST following tracheal intubation include female gender, younger age, preexisting lung disease, longer anesthesia duration, and blood-stained endotracheal tube (ETT) at extubation. The ETT size, intubation techniques, and muscle relaxant use are also associated with POST development(5).

Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, has emerged as another promising agent for attenuating airway reflexes. It provides sedative, anxiolytic, and sympatholytic effects without significant respiratory depression(6). Dexmedetomidine reduces central sympathetic output and modulates the arousal pathways, leading to smoother emergence and decreased airway hyperreactivity. Its ability to suppress extubation-related coughing has been demonstrated in several clinical studies, along with favorable effects on hemodynamic stability and postoperative analgesia(7).

Among the strategies employed to reduce this airway reactivity is intravenous (IV) lidocaine, it has been used effectively to blunt airway reflexes(8). It exerts its action by stabilizing neuronal membranes and inhibiting sodium channel activity, thereby decreasing the excitability of afferent airway nerves(9). IV lidocaine also reduces mucus secretion and limits tracheal irritation, resulting in fewer instances of coughing and sore throat. Its safety profile, rapid onset, and ease of administration make it a practical choice in a variety of surgical settings.

Magnesium sulfate, which acts as an NMDA receptor antagonist, is currently recognized as one of the most effective agents for the prevention and management of POST by peripheral NMDA receptors. Local application of magnesium can mitigate nociceptive stimuli caused by mucosal inflammation triggered by endotracheal intubation. Magnesium sulfate also exhibits, anti-inflammatory, and anti-edema properties for traumatic edema and inflammation(10).

Despite the individual benefits of lidocaine, Magnesium sulfate and dexmedetomidine, there is limited direct comparative data regarding their relative efficacy in preventing postoperative cough following FESS.

Being tested
Dexmedetomidine, Magnesium sulfate, lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    patients will receive dexmedetomidine(D) in dose 0.2 μg/kg/h infusion via syringe pump during surgery

  • Magnesium sulfateDrug

    patients will be given intravenous dose 30mg/kg.

  • lidocaineDrug

    patients will be given in one dose 1.5 mg/kg.

Study groups in NCT07213037
Study groupRoleWhat they receive
Group AActive comparatorpatients will be given intravenous dexmedetomidine plus magnesium sulphate
Receives: Drug: Dexmedetomidine; Drug: Magnesium sulfate
Group BActive comparatorpatients will be given intravenous dexmedetomidine plus lidocaine
Receives: Drug: Dexmedetomidine; Drug: lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. severity of postoperative cough

    severity of cough was graded as follows: grade 0 = no cough; grade 1 =single cough; grade 2 = more than one attack of non-sustained cough; grade 3 = repeated and sustained cough with head lift

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213037
Sponsor's protocol ID
Magnesium Sulfate vs Lidocaine
Status last verified
Oct 2025
First submitted
1 Oct 2025
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine, Magnesium sulfate and lidocaine in people with Cough Suppression, run by Assiut University.

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 1 inclusion and 8 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 8 Oct 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

severity of postoperative cough (time frame: 24 hours). 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 8 Oct 2025.

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Clinical Trial NCT07213037 | AzTrials