| CTRI Number |
CTRI/2025/07/090591 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective observational study to find out the barriers and difficulties faced in implementation of enhanced recovery after anesthesia protocol in patients posted for elective surgical procedure |
|
Scientific Title of Study
|
To analyse the barriers in implementing enhanced recovery after anesthesia (ERAA) protocol - an observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha Motghare |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Anesthesiology
AIIMS Rajkot Gujarat
Parapipaliya Khanderi Rajkot
Rajkot
GUJARAT
360010
India |
| Phone |
9860819602 |
| Fax |
|
| Email |
pacaiimsrajkot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilasha Motghare |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Anesthesiology
AIIMS Rajkot Gujarat
Parapipaliya Khanderi Rajkot
Rajkot
GUJARAT
360010
India |
| Phone |
9860819602 |
| Fax |
|
| Email |
pacaiimsrajkot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Motghare |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Anesthesiology
AIIMS Rajkot Gujarat
Parapipaliya Khanderi Rajkot
Rajkot
GUJARAT
360010
India |
| Phone |
9860819602 |
| Fax |
|
| Email |
pacaiimsrajkot@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rajkot Khanderi Parapipaliya Gujarat India 360110 |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha Motghare |
| Address |
Department of Anesthesiology
AIIMS Rajkot Khnaderi Parapipaliya Gujarat India 360110 |
| 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 Abhilasha Motghare |
All India Institute of Medical Sciences Rajkot |
Department of Anesthesiology Parapipaliya Khanderi Rajkot Gujarat India 360110
Rajkot
GUJARAT |
9860819602
pacaiimsrajkot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Rajkot Gujarat Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
the patients posted for any elective surgical procedure under anesthesia
wiling to participate in the study |
|
| ExclusionCriteria |
| Details |
the patients posted for emergency surgical procedure under anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to find out difficulties in ERAA implementation |
all throughout the perioperative period
T1- At the time of Preoperative assesment
T2 - At the time of Surgery
T3- After the surgery
At the time of discharge from PACU |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/08/2025 |
| 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="3"
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
|
The ERAS protocol has to improved perioperative outcomes The ERAA protocol proposed by Dr Mukul Kapoor focuses on anesthesia components for fastened recovery and better clinical outcomes. By doing this study we are planning to implement the ERAA protocol for the surgical patients at our institute and find out the difficulties faced in implementation of the protocol
Research Question - What components of ERAA are difficult to implement for elective surgical procedures
Hypothesis - Enhanced recovery after anesthesia is easy to implement for all elective surgical procedures |