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
|
|
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
|
|
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
|
|
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. |