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

January 6, 2025 updated by: Martina Monwar Shawky, Assiut University

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • -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.

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
patients will take magnsium sulfate 15 mg/kg on 50 ml saline
Drug: magnsium sulfate
patients will take magnsium sulfate 15 mg/kg IV
Drug: Saline
50 ml saline IV
Active Comparator: Group B
Patients will take lidocaine2% 1 mg/kg on 50 ml saline
Drug: Saline
50 ml saline IV
Drug: Lidocaine (drug)
patients will take lidocaine2% 1 mg/kg
Placebo Comparator: Group c
patients will take 50 ml saline only
Drug: Saline
50 ml saline IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tonsillectomy operation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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