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

Cough Clinical Trial

Official title:

Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray Pre Endotracheal Intubation in Adult Undergoing General Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06213116
• Other study ID #: USM/JEPeM/21080580
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2024
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Hemodynamic Instability
• Hoarseness
• Pharyngitis
• Sore Throat

Intervention

Device:
• MADgic Atomizer
Device to deliver directly lignocaine
• Lignocaine pump spray
Lignocaine 30 mg (3 puffs) given via 10mg Lignocaine Pump Spray prior to endotracheal intubation

Locations

Country	Name	City	State
Malaysia	University of Science Malaysia Hospital	Kubang kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity Grading of Post Operative Sore Throat	Numbers of participants complaining incidence of sore throat postoperatively	24 hours
Secondary	Severity Grading of Post Operative Cough	Numbers of participants complaining incidence of cough postoperatively	24 hours
Secondary	Severity grading of Hoarseness of voice	Numbers of participants complaining incidence of hoarseness of voice postoperatively	24 hours