CTRI Number |
CTRI/2021/04/033290 [Registered on: 30/04/2021] Trial Registered Prospectively |
Last Modified On: |
30/04/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
To know awareness and knowledge about Anaesthesia and Anaesthesiologist among patients coming for surgery at a higher level hospital. |
Scientific Title of Study
|
Assessment of awareness and knowledge about Anaesthesia and Anaesthesiologist among patients undergoing surgery in a tertiary care hospital. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
TANZIN DIKIT NEGI |
Designation |
POST GRADUATE STUDENT |
Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
Address |
KOTLA,VIKRAMNAGAR
NEW DELHI DEPARTMENT OF ANAESTHESIOLOGY
MAULANA AZAD MEDICAL COLLEGE
BAHADURSHAH ZAFAR MARG
NEW DELHI-110002 Central DELHI 110002 India |
Phone |
7042700697 |
Fax |
|
Email |
tanzin25negi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
MUNISHA AGARWAL |
Designation |
DIRECTOR PROFESSOR( DOCTOR) |
Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
Address |
B L TANEJA BLOCK ,DEPARTMENT OF ANAESTHESIOLOGY
MAULANA AZAD MEDICAL COLLEGE
BAHADURSHAH ZAFAR MARG
NEW DELHI-110002
Central DELHI 110002 India |
Phone |
9968604216 |
Fax |
|
Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
MUNISHA AGARWAL |
Designation |
DIRECTOR PROFESSOR( DOCTOR) |
Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
Address |
B L TANEJA BLOCK ,DEPARTMENT OF ANAESTHESIOLOGY
MAULANA AZAD MEDICAL COLLEGE
BAHADURSHAH ZAFAR MARG
NEW DELHI-110002
Central DELHI 110002 India |
Phone |
9968604216 |
Fax |
|
Email |
munisha.agarwal@gmail.com |
|
Source of Monetary or Material Support
|
MAULANA AZAD MEDICAL COLLEGE |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College |
Address |
Department of Anaesthesiology
Maulana Azad Medical College
Bahadurshah Zafar Marg, New Delhi
|
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 TANZIN DIKIT NEGI |
MAULANA AZAD MEDICAL COLLEGE |
Department of Anaesthesiology and Intensive Care
M.A.M.C. and associated hospitals,
New Delhi-110002
Central DELHI |
7042700697
tanzin25negi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: K252||Acute gastric ulcer with both hemorrhage and perforation, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.AGE 18 YEARS OR ABOVE
2.PATIENT COMING TO PREANAESTHETIC ASSESSMENT CLINIC |
|
ExclusionCriteria |
Details |
1.PATIENTS WITH DEMENTIA
2.PATIENTS WHO REFUSED TO GIVE CONSENT
3.PATIENTS WITH OTHER COGNITIVE DISORDERS
4.PATIENTS HARD OF HEARING OR FOLLOW COMMANDS
5.PATIENTS WITH HISTORY OF ANY PSYCHIATRIC DISORDERS |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
â–ª Percentage of patients having good awareness and knowledge of anaesthesia and anaesthesiologist as determined by score obtained using the questionnaire. |
10 adult patients visiting PAC clinic for their PAC evaluation before routine surgery will be consecutively recruited daily for the study |
|
Secondary Outcome
|
Outcome |
TimePoints |
▪ Correlation between patients’ variables (like age, gender, education level, previous PAC/ anaesthesia exposure) and patients’ level of awareness and knowledge about Anaesthesia and Anaesthesiologist. |
10 adult patients visiting PAC clinic for their PAC evaluation before routine surgery will be consecutively recruited daily for the study |
|
Target Sample Size
|
Total Sample Size="246" Sample Size from India="246"
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)
|
01/05/2021 |
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
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tanzin25negi@gmail.com].
- For how long will this data be available start date provided 01-04-2022 and end date provided 01-04-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Studies in the past have shown that there is limited knowledge among general public and even the patients about various aspects of Anaesthesia. The role of Anaesthetist is not only confined to the operation theatres. Anaesthetists provide vital services in other areas like pain management, palliative care and Intensive Care Units. However, patients’ understanding of Anaesthesia is evolving. More and more patients are coming to know about Anaesthesia. Pre anaesthetic assessment still remains a less cared aspect of Anaesthesia. Some patients have misconceptions regarding Anaesthesia, which influences their decision to seek anaesthetic and surgical care on time The present study will assess the awareness and knowledge of patients about anaesthesia and anaesthesiologist at a tertiary care hospital. |