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
1 other identifier
interventional
54
1 country
1
Brief Summary
The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedSeptember 8, 2022
September 1, 2022
2 years
September 1, 2022
September 2, 2022
Conditions
Keywords
Outcome Measures
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
Upto 24 hours after surgery
Secondary Outcomes (1)
The incidence and severity of Hoarseness of voice
Upto 24 hours after surgery
Study Arms (2)
M group
ACTIVE COMPARATORGroup Intubated with Macintosh laryngoscope is labelled as M group
V group
ACTIVE COMPARATORGroup Intubated with C-Mac video laryngoscope is labelled as V group
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients refusing to give consent
- Pregnant and lactating patients
- Patients with severe co-morbidities requiring postoperative ventilatory support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seth GSMC and KEM Hospital
Mumbai, Maharashtra, 400012, India
Related Publications (2)
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.
PMID: 29628570BACKGROUNDAqil 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.
PMID: 28899338BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Resident
Study Record Dates
First Submitted
September 1, 2022
First Posted
September 8, 2022
Study Start
January 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
September 8, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share