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

NCT06213116 | Completed DMC

• 1 other identifier: USM/JEPeM/21080580
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sore Throat; Cough; Hoarseness; Hemodynamic Instability

Keywords

lignocaine; MADgic Atomizer; airway anesthesia

Outcome Measures

Primary Outcomes (1)

• Severity Grading of Post Operative Sore Throat

  Numbers of participants complaining incidence of sore throat postoperatively

  24 hours

Secondary Outcomes (2)

• Severity Grading of Post Operative Cough

  24 hours

• Severity grading of Hoarseness of voice

  24 hours

Study Arms (2)

MADgic Atomizer

EXPERIMENTAL

Group M(MADgic) acting as Intervention Group: Patients receiving Lignocaine 30mg (3 alliquotes) given via MADgic Laryngotracheal Atomization Device prior to endotracheal intubation.

Device: MADgic Atomizer

Lignocaine Spray

ACTIVE COMPARATOR

Group S (Spray) acting as Control Group: Patients receiving Lignocaine 30 mg (3 puffs) given via 10mg Lignocain Pump Spray prior to endotracheal intubation.

Device: Lignocaine pump spray

Interventions

MADgic Atomizer DEVICE

Device to deliver directly lignocaine

MADgic Atomizer

Lignocaine pump spray DEVICE

Lignocaine 30 mg (3 puffs) given via 10mg Lignocaine Pump Spray prior to endotracheal intubation

Lignocaine Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Pharyngitis; Cough; Hoarseness

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Neurologic Manifestations; Nervous System Diseases

Study Officials

• rhendra hardy Mohamad Zaini, MD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and Outcome Assessor do not know type of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssociate Proffessor

Model Details: Prospective, randomized control study.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: January 19, 2024
• Study Start: December 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)