| CTRI Number |
CTRI/2024/04/065753 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of counselling before surgery in well being of patient during surgery and recovery of the patient after surgery |
|
Scientific Title of Study
|
Impact of Preoperative Personalized Counselling on Intra operative vital stability and its Role in Smooth Extubation of patients undergoing Abdominal surgery under General Anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Magesh R |
| Designation |
Resident doctor |
| Affiliation |
Pandit dindayal upadhyay medical college and hospital |
| Address |
Magesh R
Resident doctor
Department of Anesthesiology
New OPD building, P.D.U Medical college and hospital, Rajkot -360001, Gujarat, India
Rajkot
GUJARAT
360001
India |
| Phone |
7339543334 |
| Fax |
|
| Email |
mageshsasi75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mayuresh kumar pareek |
| Designation |
Assistant professor |
| Affiliation |
Pandit dindayal upadhyay Govt. medical college and hospital |
| Address |
Department of Anesthesiology
New OPD building, P.D.U Medical college and hospital, Rajkot -360001, Gujarat, India
Rajkot
GUJARAT
360001
India |
| Phone |
8200806301 |
| Fax |
|
| Email |
mayureshpareek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Magesh R |
| Designation |
Resident doctor |
| Affiliation |
Pandit dindayal upadhyay medical college and hospital |
| Address |
Magesh R
Resident doctor
Department of Anesthesiology
New OPD building, P.D.U Medical college and hospital, Rajkot -360001, Gujarat, India
Rajkot
GUJARAT
360001
India |
| Phone |
7339543334 |
| Fax |
|
| Email |
mageshsasi75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit dindayal upadhyay Govt. medical college and hospital,
Department of anesthesiology,
3rd floor OPD building, Rajkot - 360001, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Magesh R |
| Address |
Pandit dindayal upadhyay medical Govt. college and hospital, Rajkot
Jam tower chowk, Jamnagar road, Rajkot - 360001, Gujarat, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Mayuresh kumar parrek |
Pandit dindayal upadhyay Govt. medical college and hospital |
Pandit dindayal upadhyay Govt. medical college and hospital,
Department of anesthesiology, 3rd floor, OPD building, Rajkot-360001, Gujarat, India
Rajkot
GUJARAT |
8200806301
mayureshpareek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) P.D.U. Medical College, Rajkot. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who are undergoing abdominal surgery both male and female from age 20- 50 years
- ASA -(American society of anaesthesiologist) Grade I & II patients. |
|
| ExclusionCriteria |
| Details |
Patient of age group more than 50 years
American society of anaesthesiologists (ASA-grade III,IV,V )
Patient who are alcohol dependence or abuse
Patients who have severe systemic disease with poorly controlled DM or HTN, COPD, morbid obesity
Patient with cardiac abnormality,kidney disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative vital stability
Smooth extubation and recovery
|
Immediate after intubation,5mins,10mins,20mins,30mins,1hour,2hours,3hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative total analgesia requirement
Postoperative VAS score
shorter length of hospital stay |
immediate postop,5mins,10mins,20mins,30mins,1hour,2hours,3hours |
|
|
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)
|
24/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mageshsasi75@gmail.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
- Pre-operative counselling regarding surgical procedure and its complications, receive counselling regarding various steps from reversal drug to extubation, reassurance and smooth extubation and early recovery
- Preoperative, intraoperative, postoperative vitals monitoting, need of oxygen after extubation in recovery room.
- Postoperative total requireent of analgesia, monitoring of VAS score, shorter length of hosital stay and acheiving patient satisfaction score through counselling.
|