Comparing effect of two drugs given locally to a patient taken up for general anaesthesia when securing an airway device.

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/01/048818
• Lead Sponsor: Government Medical College and Hospital

Brief Summary

Securing airway is of utmost importance for an anaesthetist at the time of general anaesthesia. Laryngeal Masks Airways(LMAs) were introduced as an alternative to endotracheal tube to prevent trauma to the airway and decrease intubation response on hemodynamics of a patient during laryngoscopy. These hemodynamic responses can further be reduced by anaesthetising the airway. In this study, **we use lignocaine to anaesthetise the airway by using 2 modes of drug delivery - nebulization and lozenges**, and comparing which out of them is more efficient in blunting the **hemodynamic response during LMA insertion** ( We have used BlockBuster Airway for this study), by studying the Heart Rate, Blood Pressure and also the SpO2 of the patients.

Other parameters like ECG changes, anaphylactic reactions, systemic toxicity, circulatory disturbances and any neurological deficits will also be studied during the trial.



Over the next **1.5 years**, we aim to study the above in a group of **100 ASA - I and II patients** and conclude as to **which out of the 2 interventions will serve a better overall modality as a mode of anaesthetising the airway.**

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study Completion: 2024-03-27
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients in age group of 18-60 years 2.
• American Society of Anaesthesiologists (ASA) Status I and II 3.
• Patients undergoing surgery requiring general anaesthesia with laryngeal mask airway not requiring any other laryngeal or pharyngeal intervention.

Exclusion Criteria

• Patients allergic to lignocaine hydrochloride 2.
• Patients with difficult airway with Airway difficulty score >8 3.
• Morbid obesity BMI > 35 kg/m2 4.
• Known airway pathology 5.
• Oropharyngeal surgeries 6.
• Surgery duration more than 3 hours 7.
• Patients at increased risk of aspiration like GERD, peptic ulcer, non fasting status 8.
• Previous upper gastrointestinal surgery 9.
• Known or anticipated difficult tracheal intubation or facemask ventilation 10.
• Cervical spine injury 13.
• Pregnant Patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the Heart Rate, Noninvasive Blood Pressure, ECG changes and Oxygen Saturation in	All these parameters to be taken prior to intervention (baseline), immediately after intervention, at the time of airway insertion and 1 minute, 2 minutes, 3 minutes, 5 minutes and 10 minutes after airway insertion.
patients during BlockbusterTM LMA insertion	All these parameters to be taken prior to intervention (baseline), immediately after intervention, at the time of airway insertion and 1 minute, 2 minutes, 3 minutes, 5 minutes and 10 minutes after airway insertion.

Secondary Outcome Measures

Name	Time	Method
ECG Changes	ECG Changes- Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway
Anaphylaxis, Systemic toxicity, circulatory disturbances, neurological impairments	Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway

Trial Locations

Locations (1)

Government Medical College and Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital

🇮🇳Chandigarh, CHANDIGARH, India

Dr Vivek Pandit

Principal investigator

8198071757

dr.pandit.vivek@gmail.com