Sore ThroatNCT06213116
Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray
A study testing MADgic Atomizer and Lignocaine pump spray in people with Sore Throat and Cough, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Comparing the efficacy between Lignocaine given via MADgic Atomizer and Lignocaine Pump Spray pre endotracheal intubation in adult undergoing General Anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sore Throat, Cough, Hoarseness
- What is being tested?
- MADgic Atomizer and Lignocaine pump spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Science Malaysia Hospital
Kubang Kerian, Kelantan, 16150
About this study
Official title: 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.
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.
- Conditions
- Sore Throat, Cough, Hoarseness, Hemodynamic Instability
- Being tested
- MADgic Atomizer, Lignocaine pump spray
- Keywords
- lignocaine, MADgic Atomizer, airway anesthesia
- Medical subject headings
- Pharyngitis, Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MADgic AtomizerDevice
Device to deliver directly lignocaine
Lignocaine pump sprayDevice
Lignocaine 30 mg (3 puffs) given via 10mg Lignocaine Pump Spray prior to endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Lignocaine pump spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Grading of Post Operative Sore Throat
Numbers of participants complaining incidence of sore throat postoperatively
Measured: 24 hours
Secondary outcomes (2)
Severity Grading of Post Operative Cough
Numbers of participants complaining incidence of cough postoperatively
Measured: 24 hours
Severity grading of Hoarseness of voice
Numbers of participants complaining incidence of hoarseness of voice postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Dec 2021
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized control study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia
- Investigators
- rhendra hardy Mohamad Zaini, MD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213116
- Sponsor's protocol ID
- USM/JEPeM/21080580
- Status last verified
- May 2024
- First submitted
- 27 Sep 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray Pre Endotracheal Intubation in Adult Undergoing General Anesthesia.
- ClinicalTrials.gov ID
- NCT06213116
- Acronym / sponsor ID
- USM/JEPeM/21080580
- Conditions
- Sore Throat, Cough, Hoarseness, Hemodynamic Instability
- Keywords
- lignocaine, MADgic Atomizer, airway anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized control study.
| Arm | Type | Receives |
|---|---|---|
| MADgic Atomizer | Experimental | Device: MADgic AtomizerGroup M(MADgic) acting as Intervention Group: Patients receiving Lignocaine 30mg (3 alliquotes) given via MADgic Laryngotracheal Atomization Device prior to endotracheal intubation. |
| Lignocaine Spray | Active comparator | Device: Lignocaine pump sprayGroup S (Spray) acting as Control Group: Patients receiving Lignocaine 30 mg (3 puffs) given via 10mg Lignocain Pump Spray prior to endotracheal intubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MADgic AtomizerDevice to deliver directly lignocaine | Device | MADgic Atomizer |
| Lignocaine pump sprayLignocaine 30 mg (3 puffs) given via 10mg Lignocaine Pump Spray prior to endotracheal intubation | Device | Lignocaine Spray |
Primary outcome
Severity Grading of Post Operative Sore Throat
Time frame: 24 hours
Numbers of participants complaining incidence of sore throat postoperatively
2 secondary outcomes
Severity Grading of Post Operative Cough
Time frame: 24 hours
Severity grading of Hoarseness of voice
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rhendra hardy Mohamad Zaini, MD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MADgic Atomizer and Lignocaine pump spray in people with Sore Throat and Cough, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity Grading of Post Operative Sore Throat (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.