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CTRI Number  CTRI/2021/11/037893 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   TO KNOW THE INCIDENCE OF CARDIOVASCULAR ABNORMALITY IN HYPERTENSIVE PATIENTS UNDERGOING NEUROSURGICAL PROCEDURES: 
Scientific Title of Study   INCIDENCE OF CARDIOVASCULAR ABNORMALITY IN HYPERTENSIVE PATIENTS UNDERGOING NEUROSURGICAL PROCEDURES: A PROSPECTIVE, OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Harshini 
Designation  Junior Resident  
Affiliation  PGIMER 
Address  Dept of Anaesthesia and Intensive Care PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756500  
Fax    
Email  dr.harshinimedikondu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shiv lal Soni 
Designation  AssociateProfessor 
Affiliation  PGIMER Chandigarh 
Address  Dept of Anaesthesia and Intensive Care PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756500  
Fax    
Email  dr.shivsoni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shiv lal Soni 
Designation  AssociateProfessor 
Affiliation  PGIMER Chandigarh 
Address  Dept of Anaesthesia and Intensive Care PGIMER Chandigarh


CHANDIGARH
160012
India 
Phone  01722756500  
Fax    
Email  dr.shivsoni@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  PGIMER Sector 12 , Chandigarh 160012 
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 
Shiv lal Soni  Post Graduate Institute of Medical Education and Research Chandigarh   Main Ot Complex Division of Neuroanaesthesia Nehru Hospital PGIMER
Chandigarh
CHANDIGARH 		 9914208550

dr.shivsoni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Hypertensive patients undergoing an intracranial neurosurgical procedure
ASA PS 2
GCS 15/15
 
 
ExclusionCriteria 
Details  Pre-existing coronary artery disease (CAD) and active cardiac condition
History of chronic liver disease, chronic kidney disease and chronic obstructive airway disease
 
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study aimed to evaluate the incidence of cardiovascular abnormality with transthoracic echocardiography (pre operative) in hypertensive patients undergoing neurosurgical procedures.  Baseline , one day after surgery, 7 days after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of reversibility of cardiovascular abnormality through TTE at discharge or 7 days.
Corelation of cardiovascular abnormality with duration of hypertension and intracranial pathology 		 Baseline and one day and seven day after surgery 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be started after getting approval institutional ethics committee (IEC) and written informed consent from the patients. The study participant will be enrolled following registration in clinical trial registry-India (CTRI). All patients will have a thorough history taking, physical examination and checking of all the required investigations during pre- anaesthesia check-up. Patient’s neurological status by the Glasgow coma scale (GCS) will be noted. Patients will be assessed for the study according to the inclusion and exclusion criteria.Baseline cardiovascular examination will be done in the preoperative holding area. Pre- procedure heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse oximetry (SpO2) will be recorded as baseline values. Preoperative electrogardiogram (ECG) will be reviewed.

ABNORMAL ECG: Changes pertaining to ECG will be considered abnormal if any of the following findings will be seen in ECG

Atrioventricular block grade 1, 2, 3.
Left Ventricular Hypertrophy (LVH) defined by different voltage criteria. Heart rate <60 beats per minute as bradycardia and heart rate>100 beats per as tachycardia.

TRANSTHORACIC ECHOCARDIOGRAPHY: TTEwill be done in all the patients enrolled in the study in the preoperative holding area. TTE will be done by an experienced anesthesiologist under the guidance of a cardiac anaesthesiologist using a P21x, 5-1 MHz 21 mm broadband phased array probe of a portable echocardiographic machine. The required ECHO image and video will be recorded and subsequently evaluated by a cardiologist and/or cardiac anaesthesiologist for further analysis.

Cardiac status will be checked in the following view

  1. Parasternal long-axis view

  2. Parasternal short-axis view at basal, mid papillary and apical levels

  3. Apical 4 chamber view

  4. Apical 2 chamber view

  5. Apical 5 chamber view

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With echocardiography following cardiac function will be assessed:

a. LV Systolic function by calculating LV Ejection Fraction by using Simpson’s biplane method
b. LV Diastolic dysfunction by using pulse wave mitral inflow velocity and mitral septal annular tissue Doppler imaging

c. graded

ï‚· ï‚· ï‚· ï‚·

ABNORMAL ECHOCARDIOGRAPHY: Echocardiography will be considered abnormal if any one of the following parameters will be found during TTE

  1. LVEF <50%

  2. LVDD grade >1

  3. RWMA segments >1

Patients will be assessed in the preoperative/ pre-procedure period, intraoperative /intra- procedure period and postoperative /post-procedure period.

PRO- BNP: Pro BNP is a hormone produced by the heart. The levels increase when there are pressure changes in the heart. These changes are seen in cardiac failure and other cardiac problems.

 
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