ClinicalTrials.gg
CompletedNCT06213116Updated May 21, 2024

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

An interventional study of MADgic Atomizer and Lignocaine pump spray in Sore Throat, Cough and Hoarseness, sponsored by Universiti Sains Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.

Primary conditionCoughRegistry: PharyngitisReclassifiedWhy we changed it
Registry
Pharyngitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cough
Why
  1. The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Cough.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2021, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sore Throat
  • Cough
  • Hoarseness
  • Hemodynamic Instability

Browse trials for

Keywords

  • lignocaine
  • MADgic Atomizer
  • airway anesthesia
03

In context

Cough Reclassified

427 studies on the registry are indexed under Cough; 67 are open to participants now.

This study's enrollment of 125 is above the median of 80 across 319 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.

Compared within Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy
  • Known allergy or 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
125 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceMADgic Atomizer

    Device to deliver directly lignocaine

  • DeviceLignocaine pump spray

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

06

What researchers measure

Primary outcomes

  1. Severity Grading of Post Operative Sore Throat

    Numbers of participants complaining incidence of sore throat postoperatively

    Time frame: 24 hours

Secondary outcomes

  1. Severity Grading of Post Operative Cough

    Numbers of participants complaining incidence of cough postoperatively

    Time frame: 24 hours

  2. Severity grading of Hoarseness of voice

    Numbers of participants complaining incidence of hoarseness of voice postoperatively

    Time frame: 24 hours

07

Study locations

1 site
  • University of Science Malaysia Hospital
    Kubang kerian, Kelantan 16150, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in May 2023, 17 months.

Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 17 months is above that.

Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2023
First posted
Jan 19, 2024
StartActual
Dec 1, 2021
Primary completionActual
May 1, 2023
CompletionActual
Jul 1, 2023
Last update
May 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06213116
Responsible party
Rhendra Hardy Mohamad Zaini (Asssociate Proffessor, Universiti Sains Malaysia) — Principal investigator
First posted
Jan 19, 2024
Start date
Dec 1, 2021
Primary completion
May 1, 2023
Completion
Jul 1, 2023
Last update
May 21, 2024

Study contacts

rhendra hardy Mohamad Zaini, MD
principal investigator · Universiti Sains Malaysia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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