| CTRI Number |
CTRI/2025/11/097163 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing post operative sore throat between videolaryngoscope and Macintosh blades in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of proportion of post operative sore throat following endotracheal intubation between videolaryngoscope and macintosh blades in patients undergoing general anaethesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JADHAV MRUNAL SANJIV |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department Of anaesthesiology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9324087228 |
| Fax |
|
| Email |
jadhavms99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmanabha K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesia , Kasturba Medical College, Mangalore, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880094661 |
| Fax |
|
| Email |
padmanabhakaimer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmanabha K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesia , Kasturba Medical College, Mangalore, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880094661 |
| Fax |
|
| Email |
padmanabhakaimer@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Mangalore |
| Address |
203, Light House Hill road, Hampankatta, Mangalore, Karnataka, 575001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jadhav Mrunal Sanjiv |
KMC Hospital |
Department of anaesthesiology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA |
9324087228
jadhavms99@gmail.com |
| Jadhav Mrunal Sanjiv |
KMC Hospital |
Department of anaesthesiology, Kasturba Medical college, Mangalore
Dakshina Kannada
KARNATAKA |
9324087228
jadhavms99@gmail.com |
| Jadhav Mrunal Sanjiv |
Wenlock District Hospital |
Department of anaesthesiology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA |
9324087228
jadhavms99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18-65 years of both genders.
Elective surgery under general anesthesia.
American society of anaesthesiologists I-II patients.
Mallampatti grade of I and II.
BMI less than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Pregnant patients.
Emergency surgery.
Bariatric, cardiac, nasal, oral, head and neck surgeries.
Surgeries requiring throat pack or nasogastric tube or orogastric tube.
Surgeries requiring Rapid sequence intubation.
Patients with history of URTI.
Patients with pre operative hoarseness or sore throat.
Anticipated difficult airway.
Patients with psychiatric diagnosis.
Patients on any steroid medications or NSAIDs medication within one week of surgery.
Patients who previously had surgery within two weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative sore throat and pain |
0hr, 1hr, 6hr, 12hr post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts taken to intubate. |
Baseline |
| Complications like upper lip trauma, damage to teeth, possible airway trauma, & laryngospasm. |
Baseline |
| Time required to intubate |
Baseline |
|
|
Target Sample Size
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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 |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative sore throat (POST) is a frequent and discomforting complaint after general anaesthesia involving endotracheal intubation. Its incidence ranges between 14-62% largely due to mucosal irritation, pressure trauma and mechanical injury during laryngoscope (MCL) requires greater lifting force and neck manipulation, which may increase mucosal trauma. In contrast, videolaryngoscopes (VLs) provide an improved glottic view with minimal force and less airway manipula adadvantagetion. However, literature reveals conflicting results regarding whether VLs actually reduce the incidence of POST compared to MCLs. The present study aims to compare the proportion of POST between patients intubated with a videolaryngoscope and those intubated with a Macintosh blade. All participants will undergo standard pre-anaesthetic evalution, induction and intubation using either a VL or MCL as per group allocation. Post operative sore throat will be assessed at 0,1,6 and 12hrs after extubation using a stuructured proforma. Ethical principals of confidentiality, voluntary participation, and informed consent will be maintained throughout. No additional budget is required as all necessary equipment is available within the institution. in conclusion, this study seeks to establish whether videolaryngoscopy offers a significant advantage over the Macintosh technique in reducing the frequency and severity of post-operative sore thraot, thereby enhancing patient comfort and improving airway management practices in anaesthetic care. |