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CTRI Number  CTRI/2024/12/077825 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational Study 
Study Design  Other 
Public Title of Study   A clinical study to understand how pre-surgery anaesthetic check ups are linked to blood pressure levels before inserting a breathing tube. 
Scientific Title of Study   Correlation between Blood Pressure during Pre-operative Anaesthetic Examinations and pre-intubation Blood Pressure-An 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  Dr Moumita Das 
Designation  Post Graduate Trainee 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati ,Kamrup(Metro)Assam , Pin-781032

Kamrup
ASSAM
781032
India 
Phone  8119884152  
Fax    
Email  moumita15.das1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyam Saikia 
Designation  Associate Professor  
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup(Metro)Assam , Pin-781032

Kamrup
ASSAM
781032
India 
Phone  9706067392  
Fax    
Email  saikia.priyam80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Moumita Das 
Designation  Post Graduate Trainee 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati ,Kamrup(Metro)Assam , Pin-781032

Kamrup
ASSAM
781032
India 
Phone  8119884152  
Fax    
Email  moumita15.das1997@gmail.com  
 
Source of Monetary or Material Support  
Gauhati Medical College and Hospital,Bhangagarh,Guwahati ,Kamrup(Metro)-781032 
 
Primary Sponsor  
Name  Dr Moumita Das 
Address  Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh, Guwahati,Kamrup Metro,Assam ,Pin-781032 
Type of Sponsor  Other [Self] 
 
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 Moumita Das  Gauhati Medical College and Hospital  Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati ,Kamrup(Metro)Assam , Pin-781032
Kamrup
ASSAM 
8119884152

moumita15.das1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Gauhati Medical College and Hospital,Guwahati,Assam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: I10-I16||Hypertensive diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients in American Society Of Anaesthesiologists (ASA) I , II grade
2)Patients between age-18-60 years
3)Elective surgical cases 
 
ExclusionCriteria 
Details  1) Patients with uncontrolled Hypertension
2) Patients with valvular heart diseases
3) Patients with Cardiomyopathies
4) Patients with Sympathetic overactivity
5) Patients suffering from Secondary causes of hypertension
6)Emergency surgical cases
7)Pregnant patients
8)Patients with history of any Substance abuse
9)Patients on Psychotropic medications
10) Patients with documented malnutrition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation of preintubation blood pressure with that of blood pressure measured before, during and after anaesthetic check up.  Measurements of Blood
pressure taken 5 minutes before pre- anaesthetic examination, during pre-anaesthetic examination, and 5 minutes after Pre-Anaesthetic examination and immediately before intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the difference of preintubation BP with that of BP measured before, during & after anaesthetic check-up in Controlled hypertensives vs non hypertensives.  Measurements of BP taken 5 minutes before Pre-Anaesthetic check up, during Pre-
Anaesthetic check up, & 5 minutes after Pre-Anaesthetic check up & immediately before intubation in controlled hypertensives vs non hypertensives. 
 
Target Sample Size   Total Sample Size="372"
Sample Size from India="372" 
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)   18/12/2024 
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="0"
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  

Blood pressure (BP) is the lateral force of blood pushing against the walls of arteries and it is a fundamental cardiovascular variable. It is a major determinant of therapeutic decision, routinely measured in peri operative period.

Deviation from normal BP during general anaesthesia(GA) has been clearly linked to several adverse outcomes, so it is critically important for excellent outcomes in health careBP measured before induction/intubation is the easiest to refer as baseline BP.Many studies showed white coat hypertension (WCH) is associated with an unfavourable metabolic risk factor profile, asymptomatic organ damage, and a greater risk of future progression to high cardiovascular risk and fatal events---leading in conclusion that WCH is not clinically innocent.If WCH affects pre intubation BP as reported, a certain similar effect could be present in preoperative examination by Anaesthesiologists. Unfortunately, not many studies has been done evaluating the relationship between preoperative BP measured in clinic during preanesthetic check-up and pre intubation for GA.Hence we intend to carry out this study to examine correlation between pre intubation BP and BP measured at different times in preop period i.e. before, during, and after anaesthesiologist’s examination.

PRIMARY OBJECTIVE:

To evaluate the correlation of preintubation blood pressure with     that of blood pressure measured before,during and after anaesthetic check up.

SECONDARY OBJECTIVE:

To evaluate the difference of preintubation BP with that of BP measured before , during and after anaesthetic check up in controlled hypertensives vs non hypertensive patients.​

REFERENCES

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   10.  Koibuchi, I., Kadoi, Y., Asou, C. et al. The relationship between preoperative blood 

           pressure during anesthetic examinations and pre-intubation blood pressure. BMC 

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