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CTRI Number  CTRI/2024/05/067093 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [POST INDUCTION HYPOTENSION]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of blood flow to the brain using ultrasonography with two different methods of anesthesia induction in the elderly population 
Scientific Title of Study   Comparison of corrected carotid flows after induction with propofol using Target controlled infusion versus Manual boluses in the elderly population undergoing General Anesthesia- A Randomized Controlled Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kappa Venkata Anusha Sree 
Designation  Junior Resident 
Affiliation  AIIMS BHUBANESWAR 
Address  Department of Anesthesiology and Critical Care, First Floor of the Hospital Building, AIIMS Bhubaneswar, Khordha, Orissa, 751019, India

Khordha
ORISSA
751019
India 
Phone  6303653944  
Fax    
Email  kvanushasree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suma Rabab Ahmad 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesiology and Critical care, Faculty room no 07, 5th floor, hospital building, AIIMS Bhubaneswar, Khordha, ORISSA, 751019, INDIA

Khordha
ORISSA
751019
India 
Phone  7259000696  
Fax    
Email  anaes_suma@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Kappa Venkata Anusha Sree 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesiology and Critical care, OT Complex, 1st floor, hospital building, AIIMS Bhubaneswar, Khordha, ORISSA, 751019, INDIA

Khordha
ORISSA
751019
India 
Phone  6303653944  
Fax    
Email  kvanushasree@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical care, AIIMS Bhubaneswar,Sijua, Patrapada, Khordha, ORISSA, 751019 
 
Primary Sponsor  
Name  AIIMS BHUBANESWAR 
Address  Sijua, Patrapada, Khordha, ORISSA, 751019 
Type of Sponsor  Research institution and hospital 
 
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 Kappa Venkata Anusha Sree  AIIMS BHUBANESWAR  Department of Anesthesiology and Critical Care, First Floor of the Hospital Building, Khordha, Orissa, 751019, India
Khordha
ORISSA 		 6303653944

kvanushasree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, All India Institute of Medical Sciences,Bhubaneswar  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 
Comparator Agent  Manual boluses of propofol  In this group patients will receive an initial loading dose of 1mg/kg of propofol with 20 to 40mg every 10 seconds and then according to the patients response a maximum dose of 1.7mg/kg will be given. End points of propofol induction will be same as in TCI group. BIS will be maintained between 40 to 60 for adequate depth of anesthesia. Based on clinical requirement, any additional dose given will be noted. 
Intervention  Target controlled infusion(TCI)  This group patients will be given with propofol with initial effect site concentration of 2.5mcg/ml using schnider pharmacokinetic model, later 0.5mcg/ml will be titrated every 2 minutes. End points of propofol induction taken are loss of verbal response, eyelash reflex, no movement when mask will keep for ventillation with BIS maintaining between 40 to 60. If it goes less than 40 for more than or equal to 2 minutes, then effect site concentration will be reduced by 0.5mcg/ml. After intubation propofol infusion will be stopped. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly population of 60 years or greater and ASA 1/2 undergoing General Anesthesia with endotracheal intubation  
 
ExclusionCriteria 
Details  1) Patients who will refuse to participate in the study
2)BMI 30 or greater
3)Patients having egg allergy
4)DM with autonomic dysfunction
5)Patients with severe cognitive dysfunction
6)Patients with severe liver dysfunction
7)Patients in shock or coma patients or emergency cases
8)Preexisting tracheal intubation, tracheostomy or more than 1 attempt to intubate the patient
9)Patients with uncontrolled hypertension
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the change in corrected carotid flows(FTc) just after induction from the baeline with the propofol using Target controlled infusion versus manual boluses in the elderly population undergoing General Anesthesia   Preoperative period and intra operative period 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the correlation of baseline corrected carotid flows (FTc) with post induction hypotension (PIH) in either group.   Intraoperative period 
To compare the incidence of PIH and time for onset of PIH among the groups.  Intraoperative period 
To compare FTc and other doppler parameters during hypotension in PIH subgroup  Intraoperative period 
To compare the time for induction and total dose of propofol used for induction among the groups.  Intraoperative period 
To compare the incidence of post operative delirium among the groups  Preoperative, intraoperative and within 5 days in postoperative period  
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   30/05/2024 
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="2"
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   Post induction hypotension is most encountered during anesthesia and surgery. Especially, Elderly population are more prone to hemodynamic instability. Hypotension is related to many adverse outcomes, in severe hypotension, perfusion to organs will be compromised which may increase post operative morbidity and mortality. Propofol is one such common drug that is widely used as IV induction agent and can cause hypotension. Hypotension also relate to carotid blood flows which if decrease, hampers cerebral blood flow. Induction with Target controlled infusion(TCI) pump is known to provide better hemodynamic stability than manual boluses, which is a regular practice. To the best of our knowledge, comparison of corrected carotid flows using ultrasonography after induction with propofol using Target controlled infusion(TCI) versus manual boluses, has not been studied yet. So, in this study we will compare corrected carotid flows after induction from the baseline in TCI and manual boluses group.  
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