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CTRI Number  CTRI/2024/05/066579 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE 
Study Design  Other 
Public Title of Study   A Clinical trial to study and compare the Hemodynamic response after Endotracheal intubation in Elective and Acute trauma patients undergoing Surgery under General Anaesthesia 
Scientific Title of Study   Study on Haemodynamic changes upon Endotracheal Intubation in Patients undergoing Trauma Surgery Versus Elective General Anaesthesia Surgery - A Prospective 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  Deekshith D R 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, RIshikesh 
Address  Department of Anesthesiology All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8277772099  
Fax    
Email  deekshithdevashya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajit Kumar 
Designation  Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deekshith D R 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, RIshikesh 
Address  Department of Anesthesiology, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8277772099  
Fax    
Email  deekshithdevashya@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical SCiences, Rishikesh  
 
Primary Sponsor  
Name  Deekshith D R 
Address  Department of Anesthesiology, All India Institute of Medical Sciences, Rishikesh  
Type of Sponsor  Other [SELF FUNDED] 
 
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 
Dr Ajit Kumar  All India Institute of Medical Sciences, Rishikesh  Department of Anesthesiology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL 		 9910789377

ajitdr.ajit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ALL INIDA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Physical Status : ASA I - II
Mallam Patti Class : I,II
Acute Trauma Patients Requiring Surgical Intervention Within 72 Hours, Who are not in shock 
 
ExclusionCriteria 
Details  HISTORY OF DIFFICULT INTUBATION, ANGINA, MI, SYNCOPAL ATTACKS
PREGNANT LACTATING FEMALES
PATIENT WITH HIGH INTRACRANIAL AND INTRAOCULAR PRESSURE
KNOWN ALLERGY OR HYPERSENTIVITY REACTION TO INDUCTION AGENTS 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To Compare Systolic Blood Pressure Post Intubation in Patients Undergoing Trauma Surgery Versus Elective General Anaesthesia  At Baseline, One minute, Three minutes, Five minutes post intubation 
 
Secondary Outcome  
Outcome  TimePoints 
TO Compare Diastolic Blood Pressure, Mean Arterial Pressure And Heart rate Psot Intubation in Patients Undergoing Trauma Surgery Versus Elective General Anaesthesia
To Note the Complications Post Intubation due to Hemodynamic Changes
 		 At Baseline, One minute, Three minutes, Five minutes post intubation 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   10/05/2024 
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   I here by would like to convey that I Dr Deekshith D R will  be conducting  a study on comparing the haemodynamic changes upon endotracheal intubation in patients undergoing trauma surgery versus elective general anaesthesia surgery. I will be including 162 patients with 82 per group with inclusion and exclusion criteria as mentioned above . Data will be recorded in proforma and entered in excel master sheet. Primary aim is to compare systolic blood pressure in both groups at baseline ,1 minute,3 minutes and 5 minutes post intubation. Secondary aim is to compare diastolic blood pressure, mean arterial pressure and heart rate at baseline ,1 minute, 3 minutes and 5 minutes post intubation. The institutional ethical committee clearance have been attached . This study will be helpful in knowing duration and degree of haemodynamic changes after intubation in trauma patients undergoing general anaesthesia surgery in comparision with elective patients. 
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