Comparsion of Intravenous Injection of Magnesium Sulfate and Lidocaine Effectiveness on the Prevention of Laryngospasm and Analgesic Requirement in Tonsillectomy

NCT06761547 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: Tonsillectomy operation
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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, 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 .

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Study Arms (3)

Group A

ACTIVE COMPARATOR

patients will take magnsium sulfate 15 mg/kg on 50 ml saline

Drug: magnsium sulfate; Drug: Saline

Group B

ACTIVE COMPARATOR

Patients will take lidocaine2% 1 mg/kg on 50 ml saline

Drug: Lidocaine (drug); Drug: Saline

Group c

PLACEBO COMPARATOR

patients will take 50 ml saline only

Drug: Saline

Interventions

magnsium sulfate DRUG

patients will take magnsium sulfate 15 mg/kg IV

Group A

Lidocaine (drug) DRUG

patients will take lidocaine2% 1 mg/kg

Group B

Saline DRUG

50 ml saline IV

Group A; Group B; Group c

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 22235871 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Martina Monwar Shawky, residant doctor

CONTACT

+201282250951; Martina.16266180@med.aun.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 7, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 7, 2025

Record last verified: 2025-01