| CTRI Number |
CTRI/2025/03/082537 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Haemodynamic Stress Response To Laryngoscopy With The Macintosh McCoy And Miller Laryngoscope Blades |
|
Scientific Title of Study
|
Haemodynamic Stress Response To Laryngoscopy With The Macintosh McCoy And Miller Laryngoscope Blades - A Comparative Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Suresh |
| Designation |
Post Graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology, K S Hegde Medical Academy Deralakatte Post,
Mangaluru , India
K S Hegde Medical Academy
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9360410035 |
| Fax |
|
| Email |
poojasuresh481@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avanish Bhandary |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care , Deralakatte,
Mangaluru , Karnataka
Justice K S Hegde charitable hospital , Mangaluru, karnataka
Dakshina Kannada
KARNATAKA
Dr Avanish Bhandary
India |
| Phone |
9845679949 |
| Fax |
|
| Email |
avanishbhandary@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avanish Bhandary |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care , Deralakatte,
Mangaluru , Karnataka
Justice K S Hegde charitable hospital , Mangaluru, karnataka
Dakshina Kannada
KARNATAKA
Dr Avanish Bhandary
India |
| Phone |
9845679949 |
| Fax |
|
| Email |
avanishbhandary@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy
Deralakatte, Mangaluru, Karnataka. 575018, India |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte , Mangaluru , Karnataka , India 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avanish Bhandary |
K S Hegde Medical Academy |
Department of Anaesthesiology and Critical Care , Deralakatte,
Mangaluru , India
Dakshina Kannada
KARNATAKA |
9845679949
avanishbhandary@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KSHEMA Institutional Ethics Committee |
Approved |
| KSHEMA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z789||Other specified health status, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (3) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (4) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients age Between 18 to 60 years including male and female
Elective Surgeries with General Anaesthesia with Endo Tracheal Intubation
Patients With ASA grade I and II and Mallampatti grade I and II |
|
| ExclusionCriteria |
| Details |
Patients who Refuses The Study
Intubation Time Requiring More than Single Attempt
time for intubation Longer than 30 seconds
Patients Excluded Obesity, Diabetics Mellitus, Hypertension , LSCS and Asthma Patients
patients on Vasoactive Medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative period assessment of Systolic and Diastolic Blood pressure, Mean Arterial Pressure And Heart Rate to Monitor Haemodynamic Changes |
Intraoperative period before Laryngoscopy
After Intubation First Minute , Third Minute and Fifth Minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative period to Check the Haemodynamic Changes while Doing Laryngoscopy |
Monitoring before Laryngoscopy after intubation first, Third, Fifth Minutes |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
04/04/2025 |
| 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="0"
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
|
By Conducting This Study We Can Conclude That The Comparision Of Haemodynamic Stress Response To Laryngoscopy With Macintosh Blade , McCoy Blade , and Miller Blade In Patients Who Are Undergoing With General Anaesthesia |