| CTRI Number |
CTRI/2025/08/092206 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how frailty affects pain and stress levels in older patients after laparoscopic gallbladder surgery. |
|
Scientific Title of Study
|
Association of frailty in elderly patients undergoing laparoscopic cholecystectomy with postoperative pain and perioperative stress markers :A prospective 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 Anuradha Sharma |
| Designation |
PG Resident |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Anaesthesia, OT complex, Government Institute of Medical Sciences, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
9166499723 |
| Fax |
|
| Email |
anuhk25396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samiksha Khanuja |
| Designation |
Professor |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Anaesthesia, OT complex, Government Institute of Medical Sciences, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
9166499723 |
| Fax |
|
| Email |
ssajr123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Sharma |
| Designation |
PG Resident |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Anaesthesia,OT Complex, Government Institute of Medical Sciences, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
9166499723 |
| Fax |
|
| Email |
anuhk25396@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences, Kasna, Greater Noida Uttar pradesh,201312 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences |
| Address |
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310 |
| 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 Anuradha Sharma |
Government Institute of Medical Sciences |
Department of Anaesthesia, OT complex, Government Institute of Medical Sciences, near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH |
9166499723
anuhk25396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
All the patients equal or more than 60 year of age planned for laparoscopic cholecystectomy surgery under general anesthesia.
EXCLUSION CRITERIA:
Preoperative Amsterdam preoperative anxiety and information scale more than 11,
Patient with prior opioid addiction,
Any known mental illness.
Any other addictive disorders like smoking, alcohol, tobacco.
Any malignancies.
|
|
| ExclusionCriteria |
| Details |
Preoperative Amsterdam preoperative anxiety and information scale
(APAIS)more than 11
• Patient with prior opioid addiction.
• Any known mental illness
• Any other addictive disorders like smoking,
alcohol, tobacco.
• Any malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find the association of frailty in elderly patients undergoing Laparoscopic
cholecystectomy under general anaesthesia with post operative pain measured by
Numeric Rating Scale (NRS) in Post Operative Anaesthesia Care Unit (PACU). |
15 mins, 30 ins, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find association between frailty and PACU (Post operative anaesthesia care unit)
stay.
2.To find association between frailty and perioperative stress markers like NLR, PLR,
Serum Albumin. |
preoperatively,12 hours postoperatively,24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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="1"
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
|
According to WHO by 2050 more than 2 billion people worldwide shall be over 60 yrs
of age. Age is not a good predictor of preoperative risk stratification, as a multi
dimensional health deficit occurring during these old years are neither linear, nor
consistent and only loosely correlated with age. Frailty has been identified as a most
problematic clinical condition of ageing. With age there is a loss of physiologic
homeostatic reserve and decline in function, which in the event if stressful situations
can result in rapid decompensation. Frailty is a clinical syndrome characterized by
reduction in the physiological reserves across multiple organ systems. Frailty is a state
of increased risk as compared to others of same age. 0ur objective is to find the association of frailty in elderly patients undergoing Laparoscopic cholecystectomy under general anesthesia with post operative pain measured by Numeric Rating Scale in Post Operative Anesthesia Care Unit, association between frailty and Post operative anesthesia care unit stay ,association between frailty and perioperative stress markers like NLR, PLR, Serum Albumin. It is a prospective observational study and all the patients more than or equal to 60 yr of age planned for laparoscopic cholecystectomy surgery under general anesthesia will be included and we exclude patients with Preoperative Amsterdam preoperative anxiety and information scale if more than 11 ,Patient with prior opioid addiction, Any known mental illness ,any other addictive disorders like smoking, alcohol, tobacco , any malignancies.
We assume moderate correlation between frailty and postoperative pain, correlation
coefficient r is taken 0.3. We will be recruiting 85 consenting eligible participants for our study. |