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CompletedNCT05531617Updated Sep 8, 2022

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

An interventional study of Intubation in Hoarseness of Voice and Sore-throat, sponsored by Seth Gordhandas Sunderdas Medical College. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by Seth Gordhandas Sunderdas Medical College · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jan 2019, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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 .

02

Conditions studied

  • Hoarseness of Voice
  • Sore-throat

Keywords

  • Endotracheal tube
  • Postoperative sore throat
  • Hoarseness of voice
  • Macintosh laryngoscope
  • C-MAC video laryngoscope
03

In context

Hoarseness

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 54 is below the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Seth Gordhandas Sunderdas Medical College is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients refusing to give consent
  • Pregnant and lactating patients
  • Patients with severe co-morbidities requiring postoperative ventilatory support
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    M group

    Group Intubated with Macintosh laryngoscope is labelled as M group

    Procedure: Intubation

  • Active comparator
    V group

    Group Intubated with C-Mac video laryngoscope is labelled as V group

    Procedure: Intubation

Interventions

  • ProcedureIntubation

    Study groups Intubated with Macintosh or cmac video laryngoscopes

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Upto 24 hours after surgery

Secondary outcomes

  1. 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

    Time frame: Upto 24 hours after surgery

07

Study locations

1 site
  • Seth GSMC and KEM Hospital
    Mumbai, Maharashtra 400012, India
08

References and documents

Publications

  • Tosh P, Kadapamannil D, Rajan S, Narayani N, Kumar L. Effect of C-MAC Video Laryngoscope-aided intubations Using D-Blade on Incidence and Severity of Postoperative Sore Throat. Anesth Essays Res. 2018 Jan-Mar;12(1):140-144. doi: 10.4103/aer.AER_182_17. PubMed 29628570 ↗
  • Aqil M, Khan MU, Mansoor S, Mansoor S, Khokhar RS, Narejo AS. Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Sep 12;17(1):127. doi: 10.1186/s12871-017-0421-4. Erratum In: BMC Anesthesiol. 2018 Aug 17;18(1):112. doi: 10.1186/s12871-018-0575-8. PubMed 28899338 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jan 2021, 24 months.

Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2022
First posted
Sep 8, 2022
StartActual
Jan 1, 2019
Primary completionActual
Jan 1, 2021
CompletionActual
Jan 1, 2021
Last update
Sep 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531617
Lead sponsor
Seth Gordhandas Sunderdas Medical College
Responsible party
Gousmahammad Myageri (Senior Resident, Seth Gordhandas Sunderdas Medical College) — Principal investigator
First posted
Sep 8, 2022
Start date
Jan 1, 2019
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Sep 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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