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.
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.
- Conditions
- Cough Suppression
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients will be given intravenous dexmedetomidine plus magnesium sulphate Receives: Drug: Dexmedetomidine; Drug: Magnesium sulfate |
| Group B | Active comparator | patients 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.
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.
- First posted8 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 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 Assiut 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 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Aboelmaged Abdelmawjoud, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07213037
- Acronym / sponsor ID
- Magnesium Sulfate vs Lidocaine
- Conditions
- Cough Suppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Oct 2025 (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.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidine, Drug: Magnesium sulfatepatients will be given intravenous dexmedetomidine plus magnesium sulphate |
| Group B | Active comparator | Drug: Dexmedetomidine, Drug: lidocainepatients will be given intravenous dexmedetomidine plus lidocaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- . Active airway infection
- History of tracheal and laryngeal surgery.
- Airway tumors,
- Body mass index more than 35.
- Increased intracranial and intraocular pressure.
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 |
|---|---|---|
| Dexmedetomidinepatients will receive dexmedetomidine(D) in dose 0.2 μg/kg/h infusion via syringe pump during surgery | Drug | Group A, Group B |
| Magnesium sulfatepatients will be given intravenous dose 30mg/kg. | Drug | Group A |
| lidocainepatients will be given in one dose 1.5 mg/kg. | Drug | Group B |
Primary outcome
severity of postoperative cough
Time frame: 24 hours
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
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 8 Oct 2025.
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Cough
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.
The record lists no contact. Use the official record to reach the sponsor.
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.