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
|
|
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
|
|
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
|
|
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.
|