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CTRI Number  CTRI/2020/08/027121 [Registered on: 13/08/2020] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   What will be the level of Patient Satisfaction with our anaesthetic management ?  
Scientific Title of Study   Assessment Of Patients Satisfaction With Anaesthetic Experiences  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susheela Taxak 
Designation  Senior Professor  
Affiliation  PT. B.D. Sharma PGIMS, Rohtak  
Address  Department Of Anaesthesiology and critical care PT. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9896067416  
Fax    
Email  susheelataxak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aman Kaur Saini 
Designation  Post Graduate Student  
Affiliation  PT. B.D. Sharma PGIMS, Rohtak 
Address  Department Of Anaesthesiology and critical care 1st Floor MS Office Building PT. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9810311816  
Fax    
Email  sainiamankaur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aman Kaur Saini 
Designation  Post Graduate Student  
Affiliation  PT. B.D. Sharma PGIMS, Rohtak 
Address  Department Of Anaesthesiology and critical care 1st Floor MS Office Building PT. B.D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9810311816  
Fax    
Email  sainiamankaur@gmail.com  
 
Source of Monetary or Material Support  
1st Floor MS Office Building Department Of Anaesthesiology and critical care PT. B.D. Sharma PGIMS, Rohtak  
 
Primary Sponsor  
Name  Department Of Anaesthesiology and critical care PT BD Sharma PGIMS Rohtak 
Address  Department Of Anaesthesiology and critical care PT. B.D. Sharma PGIMS, Rohtak 
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 Aman Kaur Saini  PT. B.D. Sharma PGIMS, Rohtak, haryana  Department Of Anaesthesiology and critical care 1st Floor MS OFFICE Building PT. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA 
9810311816

sainiamankaur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee ,PT. B.D. Sharma PGIMS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either sex aged between age group 18-70 years ASA I-III undergoing elective
surgeries in various surgical specialties
 
 
ExclusionCriteria 
Details  Following patients will be excluded from the study:
1. Those having cognitive dysfunction or any other inability to finish the questionnaire
2. Those who require postoperative admission in the intensive care unit
3. Obstetric patients
4. Patients who refuse to participate in this study, will not be included in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess patients’ satisfaction with the anaesthetic experiences based on response to
questionnaire 
The patients will be interviewed within 18-24 hrs of surgery and anaesthesia using a
questionnaire.
 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the level of satisfaction with the following:-
1. Age group
2. Gender
3. Educational status
4. Residence (Urban/Rural)
5. Previous experience with anaesthesia and surgery 
The patients will be interviewed within 18-24 hrs of surgery and anaesthesia using a
questionnaire.
 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="210" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/08/2020 
Date of Study Completion (India) 26/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Evaluation of patient’s satisfaction is an important aspect of monitoring quality improvement in anaesthesia which is affected by the preoperative anaesthesia visit significantly. This visit enables the anaesthesiologist to gather information about the patient’s general status and type of surgery. It also helps to choose the type of anaesthesia, to discuss preoperative complications and their management.

 
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