Skip to main content
OpenTrials
Completed

NCT Number: NCT05531617

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hoarseness of Voice Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Sore-throat Stomatognathic Diseases Voice Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seth GSMC and KEM Hospital

Mumbai, Maharashtra, 400012, India

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intubation

Procedure

Study groups Intubated with Macintosh or cmac video laryngoscopes

Primary outcomes

  1. The incidence and severity of postoperative sore throat measured

    Time frame: Upto 24 hours after surgery

    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

Secondary outcomes

  1. The incidence and severity of Hoarseness of voice

    Time frame: Upto 24 hours after surgery

    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

Sponsors and collaborators

Lead sponsor

Seth Gordhandas Sunderdas Medical College

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.