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CTRI Number  CTRI/2023/03/050815 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On: 26/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of Pre-operative testing practices in hospital of central India with Indian Society of Anaesthesiologist guidelines.  
Scientific Title of Study   Comparison of current Pre-operative testing practices in tertiary care hospital of central India with Indian Society of Anaesthesiologist guideline - An 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  Hemant Vanjare 
Designation  Assistant Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences  
Address  Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Indore
MADHYA PRADESH
453555
India 
Phone  8109788337  
Fax    
Email  drvanjarehemant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hemant Vanjare 
Designation  Assistant Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences  
Address  Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Indore
MADHYA PRADESH
453555
India 
Phone  8109788337  
Fax    
Email  drvanjarehemant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemant Vanjare 
Designation  Assistant Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences  
Address  Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Department of Anaesthesia, 5th floor OT complex, Sri Aurobindo Institute of Medical Sciences, Indore
Indore
MADHYA PRADESH
453555
India 
Phone  8109788337  
Fax    
Email  drvanjarehemant@gmail.com  
 
Source of Monetary or Material Support  
Sri Aurobindo Institute of Medical Sciences 
 
Primary Sponsor  
Name  Sri Aurobindo Institute of Medical Sciences 
Address  Sri Aurobindo Institute of Medical Sciences, Indore-Ujjain State Highway, Near MR-10 Crossing,sanwer Road, Indore (M.P.) 453555 
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 
DrHemant Vanjare  Sri Aurobindo Institute of Medical Sciences,  Department of Anaesthesia, 5th floor OT complex, Indore-Ujjain state highway, near MR-10 crossing Sanwer road
Indore
MADHYA PRADESH 
8109788337

drvanjarehemant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Aurobindo Institute of Medical Sciences  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 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients designated ASA grade I or grade II
 
 
ExclusionCriteria 
Details  Pregnant patients,
Bedridden or Immobile patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalance of routine pre-operative investigations and impact of abnormal test result on peri-operative anaesthesia management.  6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of Pre-operative investigations and referral practices with the standard guidelines  6 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="500" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2023 
Date of Study Completion (India) 31/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/10/2023 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
PRIMARY OBJECTIVE
- To compare pre-operative investigations and referral practices with the Indian Society of Anaesthesiology guidelines and to evaluate additional resources utilised as a result of it.
- To find the prevalence and impact of abnormal test result on peri-operative anaesthesia management.

SECONDARY OBJECTIVE
- To find no. of unnecessary investigation in pre-op period and evaluate resources utilised as a result of it.
- To find patient satisfaction related to pre-operative evaluation.
- Any other observation arising during the study.



INTRODUCTION & RATIONAL OF THE STUDY: 
The practice and scope of preanaesthesia evaluation have changed dramatically in recent years, from the time when preoperative evaluation and preparation was the responsibility of surgeons, or other medical specialists, to the current status where anaesthesiologists assume the leadership role in the assessment and optimization of patients who are being prepared for surgery. (1,2)
For many years it has been usual practice in many hospitals to test apparently healthy patients preoperatively for unsuspected conditions or some hidden problem that might affect management. Such investigations include haemogram, blood glucose tests, liver and kidney function test, ECG, chest x-rays etc.(3)
The main purpose of preoperative investigations is to provide additional diagnostic and prognostic information to supplement the clinical history of a patient with the aim to provide better peri-operative management, but these investigations are criticised as having little impact on peri-operative outcomes and increases cost, causes delay and increases laboratory load.(4)
The task forces of the Indian Society of Anaesthesiologists (ISA)(5) have provided guidance on the use of pre�’operative laboratory tests. These guidelines are against the practice of routine pre�’operative laboratory tests but, the tradition of routine preoperative testing is still prevalent. As they are Indian protocols, they may be relevant to our setups
The present study will be aimed to compare the pre-operative laboratory investigation ordered with the Indian Society of Anaesthesiologist guidlines



PROCEDURE PLANNED
Patients attending Pre-Anaesthesia Clinic for pre�’anaesthesia evaluation and risk stratification before planned elective surgeries fulfilling inclusion criteria will be included in the study. Their demographic parameters, date of arrival in PAC, ASA status, Grade of surgery according to ISA guidelines will be recorded. Number of investigation already performed before arriving in PAC and their results in terms of normal and abnormal tests will be noted. Tests will be considered as abnormal if they are not within normal limits as assigned by institutional laboratory. Based on the guidelines, the tests will considered as required or not required. Number of newly diagnosed comorbidity (disease) from the investigations will also be noted. Numbers of abnormal tests and their impact will be expressed in absolute number as well as percentage scale
These patients will then be traced on the day before surgery when they undergo pre-operative evaluation again, here patients satisfaction towards pre-operative clinic will be accessed. Then on the day of surgery, patient’s plan of anaesthetic management will be noted.
An abnormal test result will be said to be impactful if it resulted in referral, delay, further investigations, retesting as well as changes in plan of anaesthetic management. Impact will be considered to be significant only if it led to a change in the perioperative anaesthetic management (i.e., postponing the elective case for further optimisation, changes in the on�’going management, altering the anaesthetic procedure and monitoring plan.)
Cost analysis will be done for every test that will be considered not necessary based on ISA guidelines. Total cost of investigations will be calculated based on the rates fixed by Central Government Health Services and the financial implications on the patient and the institute will be analysed.
The investigations done for diagnostic purposes will be excluded from this study. Any disease specific investigation which could be expected from patients history or clinical examination will not be considered impact as these will not be routine investigation.
The data will be collected by a fixed designated anaesthesiologist for the entire duration of the study. However, designated anaesthesiologist will not filter out any investigations. The designated anaesthesiologist (data collector) also will not intervene to modify the PAC process conducted by other colleague of the same rank. No surgeons or the anaesthesiologists will be informed about the study to remove bias. The patients who will be directly evaluated by the designated anaesthesiologist will not included in the study
Data collection and methods: Pre-designed Pre-structured proforma will be used for collecting the data. The data will also be entered to master chart.

 
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