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

NCT ID: NCT06213116

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-07-01

Brief Summary

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

Detailed Description

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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

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Sore Throat Cough Hoarseness Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized control study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and Outcome Assessor do not know type of intervention

Study Groups

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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.

Group Type EXPERIMENTAL

MADgic Atomizer

Intervention Type DEVICE

Device to deliver directly lignocaine

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.

Group Type ACTIVE_COMPARATOR

Lignocaine pump spray

Intervention Type DEVICE

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

Interventions

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MADgic Atomizer

Device to deliver directly lignocaine

Intervention Type DEVICE

Lignocaine pump spray

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Rhendra Hardy Mohamad Zaini

Asssociate Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rhendra hardy Mohamad Zaini, MD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

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University of Science Malaysia Hospital

Kubang Kerian, Kelantan, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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USM/JEPeM/21080580

Identifier Type: -

Identifier Source: org_study_id

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