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

September 2, 2022 updated by: Gousmahammad Myageri, Seth Gordhandas Sunderdas Medical College
The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth GSMC and KEM Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upto 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upto 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seth Gordhandas Sunderdas Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/202/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hoarseness of Voice

Clinical Trials on Intubation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe