| CTRI Number |
CTRI/2025/03/082434 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative evaluation of biochemical markers before and after intubation for patient undergoing general anaesthesia . |
|
Scientific Title of Study
|
A Comparative evaluation of biochemical markers to stress response after intubation using Macintosh Laryngoscope, C-Mac Video Laryngoscope & Fiberoptic Bronchoscope: A Prospective Randomized 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 |
Nishant Varshney |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8077318773 |
| Fax |
|
| Email |
nishantvars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishant Varshney |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8077318773 |
| Fax |
|
| Email |
nishantvars@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government 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 Nishant Varshney |
department of anaesthesiology and critical care , Jawaharlal Nehru Medical College |
Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh
Aligarh
UTTAR PRADESH |
8077318773
nishantvars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z468||Encounter for fitting and adjustment of other specified devices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
biochemical markers |
compare biochemical markers that is Serum Cortisol Serum Prolactin and HS CRP to stress response after intubation with different devices like Macintosh Laryngoscope C Mac Videolaryngoscope and Fiberoptic Bronchoscope. Total duration 6 months. |
| Intervention |
Macintosh Laryngoscope, C-Mac Video Laryngoscope, Fiber optic Bronchoscope |
compare biochemical markers pre and post intubation that is Serum Cortisol Serum Prolactin and HS CRP to stress response after intubation with different devices like Macintosh Laryngoscope C Mac Videolaryngoscope and Fiberoptic Bronchoscope. Total duration 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for elective surgery under general anaesthesia in JN Medical College and Hospital in time period between 2023-25, ASA Grade I & II, BMI 18-25Kg/sq.m, MP Grades 1 & 2 |
|
| ExclusionCriteria |
| Details |
Previous history of multiple/ failed intubation, Predicted difficult laryngoscopy and intubation in MP equal to or more than 3 grade, Any pathology of the oral cavity that may obstruct the insertion of device, Mouth opening less than 2.5cm, Patient with any endocrine disorder or on any such concerned medications, Potentially full stomach patients like trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn and at risk of esophageal reflux like hiatus hernia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes in serum cortisol level post intubation compared to pre induction using Direct Laryngoscope, Video Laryngoscope and Fiberoptic Bronchoscope. |
First baseline sample of Serum Cortisol will be taken during pre induction time and then second sample will be taken after 5 minutes of intubation, comparing three devices Direct Laryngoscope, Video Laryngoscope and Fiberoptic Bronchoscope. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare changes in serum prolactin, high sensitivity C reactive protein level post intubation compared to pre induction using the three devices |
First baseline sample of Serum prolactin, high sensitivity C reactive protein level will be taken during pre induction time & then second sample will be taken after 5 minutes of intubation, comparing three devices Direct Laryngoscope, Video Laryngoscope & Fiberoptic Bronchoscope. |
| To compare haemodynamic changes. |
To compare haemodynamic changes post intubation compared to pre induction after 1,3, & 5 minutes of intubation. |
| To compare the time required for intubation. |
To compare the time required for intubation using the three devices in seconds |
| To compare the number of attempts required for intubation |
To compare the number of attempts required for intubation |
| To compare the success rate of intubation |
To compare the success rate of intubation |
| To compare the number of adjustment maneuvers required for successful intubation. |
To compare the number of adjustment maneuvers required for successful intubation. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="1"
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
|
It is a Prospective Randomized study to do a comparative evaluation of biochemical markers to stress response after intubation using Macintosh Laryngoscope, C-Mac Video Laryngoscope & Fiberoptic Bronchoscope. Direct Laryngoscopy and endotracheal intubation are considered among the most invasive stimuli of the practice of general anaesthesia which leads to stimulation of pharyngeal and tracheolaryngeal nociceptors resulting in hemodynamic stress response. Laryngoscopy and intubation constitutes to be an important component of General Anaesthesia. These have proven to be life saving in many circumstances. However they can also causes changes in the hormonal level and hemodynamics. Endotracheal intubation has been demonstrated to impose the most intense stress to humans under general anaesthesia. As there is less studies available at present, this study will help to evaluate biochemical markers and hemodynamic changes of stress response after intubation. In our study we are going to compare three different intubation techniques Macintosh laryngoscope, a rigid video laryngoscope and fiberoptic technology to observe stress response. |