A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation

Study Overview
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Brief Summary
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The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.

Detailed Description
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Postoperative sore throat is a well known complication after endotracheal intubation. One of the major contributing factors is trauma associated with laryngoscopy. With decreased force applied to visualise cords, video laryngoscopes should decrease the incidence of postoperative sore throat. In this study we compared the incidence and severity of postoperative sore throat when laryngoscopy was done using c-mac video laryngoscope D-blade( group V) versus Macintosh laryngoscope (Group M). Method: Fifty four American society of Anaesthesiologists (ASA) 1&2 patients between age 18-60 years , undergoing laproscopic surgeries of short duration were included in this study and laryngoscopy was done with Macintosh laryngoscope in M group and with C MAC video laryngoscope D blade in V group. Patients were followed up 2hours, 6hours, 12hours and 24hours in postoperative period to see postoperative sore throat and hoarseness of voice .

Official Title
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A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation

Conditions
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Hoarseness of Voice, Sore-throat

Intervention / Treatment
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* Procedure: Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years American society of Anaesthesiologists(ASA)1 and 2 Mallampati (MPC) grading 1 and 2 laparoscopic cholecystectomy and appendectomy Surgeries of short duration(<2hour) Exclusion Criteria: Patients refusing to give consent Pregnant and lactating patients Patients with severe co-morbidities requiring postoperative ventilatory support

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective,randomised, open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M group<br>Group Intubated with Macintosh laryngoscope is labelled as M group | Procedure: Intubation<br>* Study groups Intubated with Macintosh or cmac video laryngoscopes<br>|
| Active Comparator: V group<br>Group Intubated with C-Mac video laryngoscope is labelled as V group | Procedure: Intubation<br>* Study groups Intubated with Macintosh or cmac video laryngoscopes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of postoperative sore throat measured | The incidence and severity of Postoperative sore throat is measured after surgery at 2hours, 6hours, 12hours and 24 hours based on a scaling system as described below No sore throat at any time since the operation Grade 0 Minimal - patient answered in the affirmative when asked about sore throat - Grade1 Moderate - patient complained of sore throat on his/her own - Grade 2 Severe - patient is in obvious distress-Grade 3 | Upto 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of Hoarseness of voice | The incidence and severity of Postoperative hoarseness of voice measured at 2hours, 6hours, 12hours and 24hours post surgery by scaling system as described below No complaint of hoarseness at any time since the operation - Grade 0 Minimal - minimal change in quality of speech. Patient answers in the affirmative only when enquired about - Grade 1 Moderate - moderate change in quality of speech of which the patient complains on his/her own - Grade 2 Severe - gross change in the quality of voice perceived by the observer - Grade 3 | Upto 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope