Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia

NCT ID: NCT06584461

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2024-02-05

Brief Summary

The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:

1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?

2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.

Conditions

Upper Respiratory Tract Infections; Perioperative Respiratory Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group L: IV Lidocaine Group

Participants in this group will receive a volume of weight\*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia..

Group Type: EXPERIMENTAL

Lidocaine (drug)

Intervention Type: DRUG

IV lidocaine, administered once during the induction of anesthesia.

Group P: Placebo Group

Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight\*0.15 ml) to the lidocaine group, administered at the induction of anesthesia.

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: DRUG

IV placebo (normal saline), administered once during the induction of anesthesia.

Interventions

Lidocaine (drug)

IV lidocaine, administered once during the induction of anesthesia.

Intervention Type: DRUG

Saline (NaCl 0,9 %) (placebo)

IV placebo (normal saline), administered once during the induction of anesthesia.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children aged 1 to 14 years.
• American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
• Scheduled or urgent surgery or radiological exploration under general anesthesia.
• Upper respiratory tract infection (URTI) symptoms present for less than 15 days.

Exclusion Criteria

• Refusal of participation by parents.
• Children on long-term corticosteroid or bronchodilator therapy.
• Contraindications to the use of lidocaine or other drugs used in the protocol.
• Patients who did not adhere to the study protocol.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunis University

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Trifa

Full Professor of Anesthesiology and Intensive Care, head chief of the department of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bechir Hamza Children's Hospital

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

092023

Identifier Type: -

Identifier Source: org_study_id