CTRI Number |
CTRI/2023/07/055125 [Registered on: 12/07/2023] Trial Registered Prospectively |
Last Modified On: |
11/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two laryngoscope for intubation. |
Scientific Title of Study
|
Comparison of changes in Serum Cortisol Level During Laryngoscopy And Intubation Using i-view Video Laryngoscope And Machintosh Laryngoscope In Patients Posted For Surgery Under General Anaesthesia. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
SHRUTI SHANDILYA |
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 202001 India |
Phone |
8439779747 |
Fax |
|
Email |
shrutishandilya101@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 |
07417701769 |
Fax |
|
Email |
qaziehsanali@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shruti Shandilya |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College And Hospital, Aligarh Muslim University, Aligarh |
Address |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh.
Aligarh UTTAR PRADESH 202001 India |
Phone |
8439779747 |
Fax |
|
Email |
shrutishandilya101@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College And Hospital, Aligarh Muslim University, Aligarh. |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and Critical Care |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, AMU |
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 |
Shruti Shandilya |
Jawaharlal Nehru Medical College And Hospital, Aligarh Muslim University, Aligarh |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College And Hospital, Aligarh Muslim University, Aligarh Aligarh UTTAR PRADESH |
08439779747
shrutishandilya101@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Jawaharlal Nehru Medical College And Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
i-view videolaryngoscope |
Changes in serum cortisol level during laryngoscopy and intubation will be noted in patients undergoing laparoscopic abdominal surgeries. These changes in serum cortisol will be noted pre induction and post intubation using i-viewbvideolaryngoscope. |
Comparator Agent |
Machintosh laryngoscope |
Changes in serum cortisol level pre induction and post intubation to be Compared using conventional machintosh laryngoscope with that of changes seen with i-view videolaryngoscope in patient undergoing laparoscopic abdominal surgeries. |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I and II
Weight between 40 to 70 kg
Patient planned for elective surgery
1,2 MP grades |
|
ExclusionCriteria |
Details |
Previous history of multiple/ failed intubation.
Predicted difficult laryngoscopy and intubation, MP Grade III and IV.
Any pathology of oral cavity that may obstruct the insertion of device.
Mouth opening less than 2.5 cm.
Potentially full stomach patients (trauma,morbid obesity,pregnancy,history of gastric regurgitation and heart burn) and at risk of esophageal reflux (haitus hernia). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the changes in serum cortisol level pre & post intubation using i-view videolaryngoscope & Machintosh laryngoscope. |
The serum cortisol level will be assessed at two point of time one at pre induction and one after the intubation. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare haemodynamic changes( Heart Rate And MAP) after laryngoscopy & intubation |
Pre induction
1 minute post intubation
3 minutes post intubation
5 minutes post intubation |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
Date of First Enrollment (India)
|
20/07/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
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 cause changes in the hormonal level and hemodynamics. Endotracheal intubation has been demonstrated to impose the most intense stress to humans under general anaesthesia. Triggering the physiologic mechanism off causes local inflammation and hypermetabolic process due to the general substrate mobilization and accelerated biochemical reaction. It is also associated with complex stress response characterized by neuro-humoral, immunological and metabolic alterations. Activation of sympathetic nervous system and increased release of catabolic and immuno-suppressive pituitary hormones can be attributable to surgical stress response. In clinical practice, these activations cause changes in heart rate and blood pressure and alterations in biochemical measurements like cortisol , noradrenalin, adrenalin, and dopamine levels. The type of surgical procedure, either open or laparoscopic, reflects the severity of traumatic stress imposed to the organism. Open surgery may develop much more stress than laparoscopic surgical procedures due to long surgical time, big surgical incision and local and systemic effects. Recently the use of videolaryngoscopy has become a widely accepted method in both emergency, routine and clinical anaesthesia. Poor vision at laryngoscopy (grade 3-4) is a relatively common finding (10%) even after excluding patients in whom difficult tracheal intubation was anticipated and an alternative technique was chosen. And in many patients there is a need of more than 3 laryngoscopies (1.9%) and failed direct laryngoscopy may occur though it is a rare event(0.1%). Ease of handling, high success rate in patients with normal and difficult airways and a steep learning curves make these devices very popular among physicians. Video laryngoscopes have now been included among first aid devices for the management of difficult situations by Difficult Airway Society (DAS). i-view laryngoscope is among the latest video laryngoscope in current anaesthetic practice It is distributed by the intersurgical company, providing the option of video laryngoscopy wherever you might need to intubate. i-view is ready to use seconds after removing from packaging.The ergonomic design ensures i-view is easy to use and integrated LCD screen provides an optimal view in variety of light conditions. In the present study, we therefore intend to compare the changes in S.Cortisol level after laryngoscopy and Intubation using the two devices i.e. i-view and Macintosh laryngoscope |