CoughPhase 3MgSO4/DEXNCT06979141
Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia
A Phase 3 study testing Dexmedetomidine, Magnesium sulfate and Lidocaine in people with Cough, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this prospective randomized controlled double-blinded study is to compare the efficacy of dexmedetomidine, MgSO4 and lidocaine for cough suppression during general anesthetic emergence as regard number and severity. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cough
- What is being tested?
- Dexmedetomidine, Magnesium sulfate and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2025to 1 Aug 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 21-60 years.
- Both genders.
- Body mass index < 30 kg/ m2
- American Society of Anesthesiology (ASA) physical status I-II.
- Mallampati score class I or II.
- Patients undergoing surgery under general anesthesia.
Who cannot join
- Known allergy to study drugs.
- History of psychiatric illness.
- Patients with major organ diseases.
- Pre-existing neurological deficits.
- Body mass index >30 kg/m2.
- Active airway infection or history of tracheal and laryngeal surgery.
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- Lower esophageal sphincter incompetence (and reflux).
- Increased intracranial and intraocular pressure.
- Use of cough-inducing medications
- Pregnant, and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Al-Azhar university Assiut, Egypt.
Asyut, 2091110
Mahmoud T Abd Elhafeez, Specialist.Mcs, mahmoud.talaat750@gmail.com
About this study
Official title: Comparative Study Between Efficacy of Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression During General Anesthetic Emergence
The aim of this prospective randomized controlled double-blinded study is to compare the efficacy of dexmedetomidine, MgSO4 and lidocaine for cough suppression during general anesthetic emergence as regard number and severity.
- Conditions
- Cough
- Being tested
- Dexmedetomidine, Magnesium sulfate, Lidocaine, normal saline
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called dex
Patients will receive 0.5 μg/kg dexmedetomidine in 10ml normal saline 10 min before the end of surgery.
Magnesium sulfateDrug
Also called MgSO4
Patients will receive 30 mg/kg IV magnesium sulfate 50% 10 min before the end of surgery.
LidocaineDrug
Patients will receive lidocaine 1.5 mg/kg lidocaine 10 min before the end of surgery.
normal salineDrug
Patients will receive 10 ml normal saline 10 min before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group ( D group ) | Active comparator | Patients will receive 0.5 μg/kg dexmedetomidine in 10 ml normal saline 10 min before the end of surgery. Receives: Drug: Dexmedetomidine |
| Magnesium sulfate group ( M group ) | Active comparator | Patients will receive 30 mg/kg IV magnesium sulfate 50% in 10 ml normal saline 10 min before the end of surgery. Receives: Drug: Magnesium sulfate |
| Lidocaine group ( L group ) | Active comparator | Patients will receive lidocaine 1.5 mg/kg lidocaine in 10 ml normal saline 10 min before the end of surgery. Receives: Drug: Lidocaine |
| Control group ( C group ) | Placebo comparator | Patients will receive 10 ml normal saline 10 min before the end of surgery. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough suppression as regard number and severity.
Coughing severity will be classified using the 3 point scale described by Minogue et al.: 1 = mild, single cough, 2 = moderate (lasting for <5 seconds) cough, and severe (lasting for >5 seconds) cough.
Measured: at 0 and 10,20,30,40 minutes after endotracheal extubation.
Secondary outcomes (4)
Intraoperative heart rate (HR).
Changes in Intraoperative heart rate. change in heart rate per minute (HR/minute) will be all measured from the patient's arrival at the operating room to the end of surgery.
Measured: at 15-minutes interval.
Intraoperative mean arterial blood pressure (MAP).
Changes in Intraoperative mean arterial blood pressure (MAP). change in mean arterial blood pressure (MAP) in mmHg will be all measured from the patient's arrival at the operating room to the end of surgery.
Measured: at 15-minutes interval.
Intraoperative arterial oxygen saturation (Spo2).
Changes in Intraoperative arterial oxygen saturation (Spo2%). change in arterial oxygen saturation (Spo2%). be all measured from the patient's arrival at the operating room to the end of surgery.
Measured: at 15-minutes interval.
Sedation score.
Sedation score will be recorded using the Ramsay sedation score (Ramsay et al., 1974).
Measured: at 0,10,20,30, and 40 minutes after tracheal extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start2 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Talaat Abd Elhafeez Ahmed, Al-Azhar University
- Investigators
- Mahmoud T Abd Elhafeez, Specialist.Mcs, Principal investigator, mahmoud.talaat750@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979141
- Sponsor's protocol ID
- MD/AZ.AST./AIP029/7/240/2/2025
- Acronym
- MgSO4/DEX
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Efficacy of Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression During General Anesthetic Emergence
- ClinicalTrials.gov ID
- NCT06979141
- Acronym / sponsor ID
- MgSO4/DEX / MD/AZ.AST./AIP029/7/240/2/2025
- Conditions
- Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 May 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.
The aim of this prospective randomized controlled double-blinded study is to compare the efficacy of dexmedetomidine, MgSO4 and lidocaine for cough suppression during general anesthetic emergence as regard number and severity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group ( D group ) | Active comparator | Drug: DexmedetomidinePatients will receive 0.5 μg/kg dexmedetomidine in 10 ml normal saline 10 min before the end of surgery. |
| Magnesium sulfate group ( M group ) | Active comparator | Drug: Magnesium sulfatePatients will receive 30 mg/kg IV magnesium sulfate 50% in 10 ml normal saline 10 min before the end of surgery. |
| Lidocaine group ( L group ) | Active comparator | Drug: LidocainePatients will receive lidocaine 1.5 mg/kg lidocaine in 10 ml normal saline 10 min before the end of surgery. |
| Control group ( C group ) | Placebo comparator | Drug: normal salinePatients will receive 10 ml normal saline 10 min before the end of surgery. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 21-60 years.
- Both genders.
- Body mass index < 30 kg/ m2
- American Society of Anesthesiology (ASA) physical status I-II.
- Mallampati score class I or II.
Key exclusion criteria (10 listed)
- Known allergy to study drugs.
- History of psychiatric illness.
- Patients with major organ diseases.
- Pre-existing neurological deficits.
- Body mass index >30 kg/m2.
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 |
|---|---|---|
| DexmedetomidineAlso: dexPatients will receive 0.5 μg/kg dexmedetomidine in 10ml normal saline 10 min before the end of surgery. | Drug | Dexmedetomidine group ( D group ) |
| Magnesium sulfateAlso: MgSO4Patients will receive 30 mg/kg IV magnesium sulfate 50% 10 min before the end of surgery. | Drug | Magnesium sulfate group ( M group ) |
| LidocainePatients will receive lidocaine 1.5 mg/kg lidocaine 10 min before the end of surgery. | Drug | Lidocaine group ( L group ) |
| normal salinePatients will receive 10 ml normal saline 10 min before the end of surgery. | Drug | Control group ( C group ) |
Primary outcome
Cough suppression as regard number and severity.
Time frame: at 0 and 10,20,30,40 minutes after endotracheal extubation.
Coughing severity will be classified using the 3 point scale described by Minogue et al.: 1 = mild, single cough, 2 = moderate (lasting for <5 seconds) cough, and severe (lasting for >5 seconds) cough.
4 secondary outcomes
Intraoperative heart rate (HR).
Time frame: at 15-minutes interval.
Intraoperative mean arterial blood pressure (MAP).
Time frame: at 15-minutes interval.
Intraoperative arterial oxygen saturation (Spo2).
Time frame: at 15-minutes interval.
Sedation score.
Time frame: at 0,10,20,30, and 40 minutes after tracheal 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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Mahmoud T Abd Elhafeez, Specialist.Mcs principal investigator
mahmoud.talaat750@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Magnesium sulfate and Lidocaine in people with Cough, run by Al-Azhar 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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.
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?
Contact Medhat H Allam, lecturer.MD (1003012989 ext. +020, Medhathelaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough suppression as regard number and severity. (time frame: at 0 and 10,20,30,40 minutes after endotracheal 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 11 Jun 2025.