Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Sore Throat; Cough; Hoarseness
• Interventions: Device: Lignocaine pump spray; Device: MADgic Atomizer

• Registration Number: NCT06213116
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

Comparing the efficacy between Lignocaine given via MADgic Atomizer and Lignocaine Pump Spray pre endotracheal intubation in adult undergoing General Anesthesia.

Detailed Description

Comparing the efficacy of Lignocaine given via 2 device (Lignocaine Spray and MADGIC Atomizer) on hemodinamic parameters postintubations and severity grading of post operative sore throat, cough and hoarseness of voice.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2024-01-13
• Study First Posted: 2024-01-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Adult with the age of 18 to 65 years old
• Gender of both male and female
• Planned for elective surgery scheduled at General Operation Theatre that require elective intubation for general anesthesia
• American Society Anaesthesiologist (ASA) preoperative physical status assessment of 1 and 2
• Airway assessment Malampati scoring 1and 2.

Exclusion Criteria

• Pregnancy
• Known allergy or hypersensitivity to Lignocaine
• Pre existing sore throat or hoarseness of voice identified during preoperative assessment.
• The use of airway device other than endotracheal tube (ETT) such Laryngeal Mask airway/Supraglottic Device'
• Oral and neck surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lignocaine Spray	Lignocaine pump spray	Group S (Spray) acting as Control Group: Patients receiving Lignocaine 30 mg (3 puffs) given via 10mg Lignocain Pump Spray prior to endotracheal intubation.
MADgic Atomizer	MADgic Atomizer	Group M(MADgic) acting as Intervention Group: Patients receiving Lignocaine 30mg (3 alliquotes) given via MADgic Laryngotracheal Atomization Device prior to endotracheal intubation.

Primary Outcome Measures

Name	Time	Method
Severity Grading of Post Operative Sore Throat	24 hours	Numbers of participants complaining incidence of sore throat postoperatively

Secondary Outcome Measures

Name	Time	Method
Severity Grading of Post Operative Cough	24 hours	Numbers of participants complaining incidence of cough postoperatively
Severity grading of Hoarseness of voice	24 hours	Numbers of participants complaining incidence of hoarseness of voice postoperatively

Trial Locations

Locations (1)

University of Science Malaysia Hospital; 🇲🇾 Kubang kerian, Kelantan, Malaysia