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CTRI Number  CTRI/2022/12/047981 [Registered on: 08/12/2022] Trial Registered Prospectively
Last Modified On: 07/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Anesthesia inducing drugs on blood pressure and heart rate in hypertensive patients. 
Scientific Title of Study   A comparative study of inducing agent Propofol and Sodium Thiopental on hemodynamic changes during induction of general anesthesia in hypertensive patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sangeeth C 
Designation  Junior resident 
Affiliation  AIIMS RAIPUR 
Address  Department of Anesthesiology, B-Block Fourth floor AIIMS Raipur Tatibandh Raipur.

Raipur
CHHATTISGARH
492099
India 
Phone  7000529561  
Fax    
Email  mailsangeeth111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandkishore Agrawal 
Designation  Head of the department and professor 
Affiliation  AIIMS Raipur 
Address  Department of Anesthesiology B-Block, Fourth floor AIIMS Raipur Tatibandh Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9373103294  
Fax    
Email  nkagrawal1963@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeeth C 
Designation  Junior resident 
Affiliation  AIIMS RAIPUR 
Address  Department of Anesthesiology, B-Block Fourth floor AIIMS Raipur Tatibandh Raipur.

Raipur
CHHATTISGARH
492099
India 
Phone  7000529561  
Fax    
Email  mailsangeeth111@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RAIPUR 
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  AIIMS Raipur Tatibandh, GE Road, Raipur Chhattishgarh PIN 492099 
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 
Dr Sangeeth C  AIIMS Raipur  Department of Anesthesiology, B-Block Fourth floor AIIMS Raipur Tatibandh Raipur.
Raipur
CHHATTISGARH 
7000529561

mailsangeeth111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Propofol  Propofol will be used as induction agent for inducing general anesthesia 
Comparator Agent  Sodium Thiopentone  Sodium Thiopentone will be used as induction agent to induce general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing surgery under general anaesthesia with
1) ASA II or III
2) Male or female
3) Controlled hypertensive patient
4) Duration of surgery more than 30 minutes 
 
ExclusionCriteria 
Details  Patient refusal
Allergy to any medication
Allergy to egg or soya bean
History of ischemic heart disease, myocardial infraction, asthma and diabetes mellitus
Any other contraindication for the drugs
Difficult airway
Obesity 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood pressure values  baseline, 1 minute, 2minute, 3 minute, 4 minute post administration of induction agents and 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 6 minute, 7 minute, 8 minute, 10 minute, 15 minute, 20 minute, 25 minute, 30 minute after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Best inhalational agent with respect to hemodynamic stability  baseline, 1 minute, 2minute, 3 minute, 4 minute post administration of induction agents and 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 6 minute, 7 minute, 8 minute, 10 minute, 15 minute, 20 minute, 25 minute, 30 minute after intubation 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   13/12/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
In the current era anesthesia is required for almost all surgeries that includes amnesia, analgesia, muscle relaxation and homoeostasis. Ideal induction agent for General Anaesthesia should have hemodynamic stability, minimal respiratory side effects, rapid clearance, lack of pain on injection, rapid return of consciousness. Induction is the most stressful moment of general anaesthesia. Commonly used induction agents are propofol, thiopentone, etomidate and ketamine. Increase in hemodynamic instability is more prominent in hypertensive patients, many times profound decrease in BP is observed. Propofol produce nitric oxide and cause bradycardia and hypotension due to reduction in preload and afterload. This study is aimed at comparing haemodynamic responses associated with anaesthetic induction with propofol and sodium thiopentone in hypertensive patients.
Hypertension is an modifiable risk factor cardiovascular morbidity and mortality. Less than half of those who has hypertension are diagnosed with hypertension others are left undiagnosed. Aetiology of hypertension is a complex
interaction between genetic and Pathophysiological mechanisms which involves multiple systems. Both lifestyle modification and pharmacological therapy are effective in lower blood pressure. Hypertension can primary
(essential hypertension) or secondary hypertension.
In this study hemodynamic responses of propofol and thiopentone in hypertensive is compared. Blood pressure, Heart rate and SPO2 will be measured at regular interval after giving anyone of the drugs. These data will be used compared and the efffect of both drug on hemodynamics in hypertensive patient. 
 
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