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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05531617
Enrollment
54
Registered
2022-09-08
Start date
2019-01-01
Completion date
2021-01-01
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hoarseness of Voice, Sore-throat

Keywords

Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope

Brief summary

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

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 .

Interventions

PROCEDUREIntubation

Study groups Intubated with Macintosh or cmac video laryngoscopes

Sponsors

Seth Gordhandas Sunderdas Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

A prospective,randomised, open label study

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence and severity of postoperative sore throat measuredUpto 24 hours after surgeryThe 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

MeasureTime frameDescription
The incidence and severity of Hoarseness of voiceUpto 24 hours after surgeryThe 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026