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

January 13, 2024 updated by: Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Malaysia
    • Kelantan
      • Kubang kerian, Kelantan, Malaysia, 16150
        • University of Science Malaysia Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: MADgic Atomizer
Device to deliver directly lignocaine
Active Comparator: Lignocaine 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.
Device: Lignocaine pump spray
Lignocaine 30 mg (3 puffs) given via 10mg Lignocain Pump Spray prior to endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity Grading of Post Operative Sore Throat
Time Frame: 24 hours
Numbers of participants complaining incidence of sore throat postoperatively
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity Grading of Post Operative Cough
Time Frame: 24 hours
Numbers of participants complaining incidence of cough postoperatively
24 hours
Severity grading of Hoarseness of voice
Time Frame: 24 hours
Numbers of participants complaining incidence of hoarseness of voice postoperatively
24 hours

Collaborators and Investigators

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

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: rhendra hardy Mohamad Zaini, MD, Universiti Sains Malaysia

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 (Actual)

December 1, 2021

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/21080580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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