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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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