| CTRI Number |
CTRI/2025/08/093742 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
SEVERITY OF POST OPERATIVE SORE THROAT FOLLOWING USE OF DIRECT VERSUS VIDEO LARYNGOSCOPE |
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Scientific Title of Study
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COMPARISON OF SEVERITY OF POST OPERATIVE SORE THROAT FOLLOWING LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION USING DIRECT MCINTOSH LARYNGOSCOPE VERSUS VIDEO LARYNGOSCOPE
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuraag kaur brar |
| Designation |
PG student |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of Anesthesiology and intensive care,
Adesh Institute of Medical Sciences and Research
Bathinda
Punjab
India
Bathinda
PUNJAB
151101
India |
| Phone |
9988994711 |
| Fax |
|
| Email |
braranuraag@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Mridul Madhav Panditrao |
| Designation |
Professor and Head |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of anesthesiology and intensive care,
Adesh Institute of Medical Sciences and Research
Bathinda
Punjab
India
Bathinda
PUNJAB
151101
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Anuraag kaur brar |
| Designation |
PG student |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of Anesthesiology and intensive care,
Adesh Institute of Medical Sciences and Research
Bathinda
Punjab
India
Bathinda
PUNJAB
151101
India |
| Phone |
9988994711 |
| Fax |
|
| Email |
braranuraag@gmail.com |
|
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Source of Monetary or Material Support
|
| Adesh institute of medical sciences and research
Bathinda
151001
Punjab
India |
|
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Primary Sponsor
|
| Name |
Adesh University |
| Address |
Department of Anesthesiology and intensive care,Adesh Institute of Medical Sciences and Research
Bathinda
151001
Punjab
India |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anuraag kaur brar |
Adesh Institute of Medical Sciences and Research Bathinda |
Department of Anesthesiology and Intensive Care,Adesh Institute of Medical Sciences and Research, Bathinda
151001
Punjab
India
Bathinda
PUNJAB |
9988994711
braranuraag@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Direct Mcintosh laryngoscope and Video laryngoscope |
Severity of sore throat will be assessed using VAS score post operatively following endotracheal intubation using direct Mcintosh laryngoscope versus video laryngoscope in patients undergoing elective/planned surgeries under balanced general anaesthesia. VAS score will be calculated at different time points post operatively and their severity will be compared and intubation difficulty will be assessed as well
|
| Intervention |
Endotracheal intubation using direct Mcintosh laryngoscope or video laryngoscope |
Intravenous operatively hemodynamic changes and • Conox® monitor will be used for depth of anaesthesia monitoring tools that capture the EEG signal from the brain, which has two parameters, namely qCON and qNOX. qCON is an index of the level of anaesthesia depth, while qNOX is a predictive level of response to pain stimuli. 20G IV cannula will be already in place when patient is taken to OT and preloading of crystalloid with 10ml/kg of fluid will be done.Premedication: Midazolam 0.02 mg/kg IV, Glycopyrrolate 0.004mg/kg IV, Butorphanol 20 mcg/kg IV
All Patients will be oxygenated with 100% oxygen for 3mins
Induction: Propofol 1-2 mg/kg IV
Muscle relaxation: Rocuronium 0.6 mg/kg
Maintenance: Sevoflurane in oxygen-air mixture
Reversal: Sugammadex (2mg/kg)
Expected duration of surgery between 1-3 hours
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I-II
Scheduled for elective surgery under general anaesthesia requiring endotracheal intubation
Expected duration of surgery between 1-3 hours
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| ExclusionCriteria |
| Details |
History of recent upper respiratory tract infection (within 2 weeks)
Pre-existing sore throat or hoarseness
Previous neck surgery or radiation
History of gastroesophageal reflux disease
Patients requiring rapid sequence induction
Surgery involving the oral cavity, pharynx, or larynx
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare the severity of post operative throat pain (using a validated Visual Analogue Scale) following endotracheal intubation with direct Mcintosh laryngoscope versus video laryngoscope at multiple time points post-extubation (upto 24 hours) |
Throat pain assessment using VAS (Visual Analogue Scale) at:
Immediately after extubation (once patient is fully awake)
2 hours post-extubation
6 hours post-extubation
12 hours post-extubation
24 hours post-extubation
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|
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Secondary Outcome
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| Outcome |
TimePoints |
1. To compare the severity of post-intubation sore throat using POST score with both laryngoscopy technique.
2. To determine the correlation between the degree of intubation difficulty using specifically devised & validated TEAG (Tongue, Epiglottis, Arytenoid tubercles, Glottis) score (to be validated) based on Cormack-Lehane grade & POGO score.
3. To compare the secondary airway-related adverse outcomes between direct Mcintosh laryngoscope & video laryngoscope, using intubation difficulty scale (IDS)
4. To compare hemodynamic changes during laryngoscopy & endotracheal intubation (heart rate, blood pressure)
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Throat pain assessment using VAS (Visual Analogue Scale) at:
Immediately after extubation (once patient is fully awake)
2 hours post-extubation
6 hours post-extubation
12 hours post-extubation
24 hours post-extubation
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Target Sample Size
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Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
18/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [braranuraag@gmail.com].
- For how long will this data be available start date provided 21-08-2025 and end date provided 28-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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Direct laryngoscopy (DL) using a Mcintosh blade has been considered as the gold standard for performing endotracheal intubation in adults worldwide. While effective in most routine cases,it can lead to potential mucosal damage, edema, and subsequent throat discomfort (Jaensson et al., 2012) and autonomic (Sympathetic pressor) response. Post-operative sore throat (POST) is recognized as one of the most common complications following endotracheal intubation, with reported incidence ranging from 21% to 65% following general anesthesia with endotracheal intubation (El-Boghdadly et al., 2016). The benefits of VL in terms of improved glottic visualization, higher first-attempt success rates, and utility in difficult airway scenarios are well-established (Aziz et al., 2012). Despite these established benefits, the impact of VL complications like POST and associated throat pain remains less well-defined. This study aims to address these gaps in the literature by conducting a prospective, randomized, controlled trial comparing the severity of throat pain following endotracheal intubation using direct Mcintosh laryngoscope versus video laryngoscope in patients undergoing elective surgeries requiring general anesthesia with endotracheal intubation
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