TonsillectomyPhase 3NCT06761547
Comparsion of Intravenous Injection of Magnesium Sulfate and Lidocaine Effectiveness on the Prevention of Laryngospasm and Analgesic Requirement in Tonsillectomy
A Phase 3 study testing magnsium sulfate, Lidocaine (drug) and Saline in people with Tonsillectomy, run by Assiut University.
Trial summary
Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm . Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- magnsium sulfate, Lidocaine (drug) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2027
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -ASA physical status I-II.
- Both sexes.
- Age: children 3-14years old.
- patients subjected for tonsillectomy or adeno-tonsillectomy surgery with parental consent for participation in the study.
Who cannot join
- - patients who refused to participate in this study.
- History of allergic response to magnesium sulfate and liodcaine .
- the Prescence of cardiovascular, respiratory and kidney diseases.
- A recent history of upper respiratory tract infection and febrile illness.
- History of mythenia gravis.
- patients subjected for adeno-tonsillectomy with myringotomy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .
Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .
Read more
Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.
Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .
Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .
Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy the goal of the study Comparing the effectiveness of magnesium sulfate and lidocaine in prevention of post tonsillectomy complication .
Read the detailed description
Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .
Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .
Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.
Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .
Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .
Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy
- Conditions
- Tonsillectomy
- Being tested
- magnsium sulfate, Lidocaine (drug), Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnsium sulfateDrug
patients will take magnsium sulfate 15 mg/kg IV
Lidocaine (drug)Drug
patients will take lidocaine2% 1 mg/kg
SalineDrug
50 ml saline IV
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients will take magnsium sulfate 15 mg/kg on 50 ml saline Receives: Drug: magnsium sulfate; Drug: Saline |
| Group B | Active comparator | Patients will take lidocaine2% 1 mg/kg on 50 ml saline Receives: Drug: Lidocaine (drug); Drug: Saline |
| Group c | Placebo comparator | patients will take 50 ml saline only Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of laryngospasm in three groups.
Common signs of laryngospasm include inspiratory stridor which may progress to complete obstruction, increased respiratory effort, tracheal tug, paradoxical respiratory effort, oxygen desaturation with or without bradycardia, or airway obstruction which does not respond to a Guedel airway. When these occur, either alone or in combination, laryngospasm is considered
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 posted7 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Monwar Shawky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761547
- Sponsor's protocol ID
- Tonsillectomy operation
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Mansson I, Roos K, Hessen Soderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. doi: 10.3109/00016489.2011.644252. Epub 2012 Jan 11.
PubMed 22235871
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparsion of Intravenous Injection of Magnesium Sulfate and Lidocaine Effectiveness on the Prevention of Laryngospasm and Analgesic Requirement in Tonsillectomy
- ClinicalTrials.gov ID
- NCT06761547
- Acronym / sponsor ID
- Tonsillectomy operation
- Conditions
- Tonsillectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Jan 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.
Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .
Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .
Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.
Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .
Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .
Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy the goal of the study Comparing the effectiveness of magnesium sulfate and lidocaine in prevention of post tonsillectomy complication .
Detailed description
Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .
Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .
Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.
Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .
Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .
Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: magnsium sulfate, Drug: Salinepatients will take magnsium sulfate 15 mg/kg on 50 ml saline |
| Group B | Active comparator | Drug: Lidocaine (drug), Drug: SalinePatients will take lidocaine2% 1 mg/kg on 50 ml saline |
| Group c | Placebo comparator | Drug: Salinepatients will take 50 ml saline only |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- -ASA physical status I-II.
- Both sexes.
- Age: children 3-14years old.
- patients subjected for tonsillectomy or adeno-tonsillectomy surgery with parental consent for participation in the study.
Key exclusion criteria (6 listed)
- - patients who refused to participate in this study.
- History of allergic response to magnesium sulfate and liodcaine .
- the Prescence of cardiovascular, respiratory and kidney diseases.
- A recent history of upper respiratory tract infection and febrile illness.
- History of mythenia gravis.
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 |
|---|---|---|
| magnsium sulfatepatients will take magnsium sulfate 15 mg/kg IV | Drug | Group A |
| Lidocaine (drug)patients will take lidocaine2% 1 mg/kg | Drug | Group B |
| Saline50 ml saline IV | Drug | Group A, Group B, Group c |
Primary outcome
The incidence of laryngospasm in three groups.
Time frame: 24 hours
Common signs of laryngospasm include inspiratory stridor which may progress to complete obstruction, increased respiratory effort, tracheal tug, paradoxical respiratory effort, oxygen desaturation with or without bradycardia, or airway obstruction which does not respond to a Guedel airway. When these occur, either alone or in combination, laryngospasm is considered
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 7 Jan 2025.
- Results publication: PubMed 22235871Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Mansson I, Roos K, Hessen Soderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. doi: 10.3109/00016489.2011.644252. Epub 2012 Jan 11.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnsium sulfate, Lidocaine (drug) and Saline in people with Tonsillectomy, 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 4 inclusion and 6 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 7 Jan 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. 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 Martina Monwar Shawky, residant doctor (+201282250951, Martina.16266180@med.aun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of laryngospasm in three groups. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761547, which also lists 1 linked publication.
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 7 Jan 2025.