| CTRI Number |
CTRI/2024/12/078567 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative Study of Patient Preferences: General Anesthesia versus Regional Anesthesia for Elective Surgeries |
|
Scientific Title of Study
|
A study to compare the preference of general anaesthesia vs regional anaesthesia in patients posted for elective surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Jaggi |
| Designation |
Resident doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8780627207 |
| Fax |
|
| Email |
tanyajaggi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Medical Superintendent |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Medical Superintendent |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodia, Pipariya, Vadodara, Gujarat, India, pin- 391760 |
| Type of Sponsor |
Private 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 Tanya Jaggi |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General OT complex, 2nd floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat, pin-391760
Vadodara
GUJARAT |
8780627207
tanyajaggi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing to sign the written & informed consent.
2) Patients posted for elective surgeries.
3) Patients willing to fill out the questionnaire.
4) Patients belonging to American Society of anesthesiologists grade I, II amd |
|
| ExclusionCriteria |
| Details |
1) Patient’s refusal from taking part in the study.
2) Patients being taken for emergency surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This prospective, observational study will help us to assess the patient knowledge about
modes of anaesthesia, their preferences, reasons for the same and will also help in
increasing awareness so that patients can be more involved and take better decisions for
their surgical treatment plans.
|
Day - 1
Questionnaire to be given and assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Further the outcomes can be that they provide valuable insights into patient preferences, clinical effectiveness, & economic implications of general anesthesia versus regional anesthesia for elective surgeries. |
Day- 1
Questionnaire to be given & assessed. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/01/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A questionnaire based study to be conducted to investigate and compare patient preferences between general anesthesia and regional anesthesia for elective surgical procedures. To assess the patient knowledge about modes of anaesthesia, their preferences, reasons for the same and will also help in
increasing awareness so that patients can be more involved and take better decisions for their surgical treatment plans. |