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Clinical Trials/CTRI/2025/08/092206
CTRI/2025/08/092206Not yet recruitingNot Applicable

Association of frailty in elderly patients undergoing laparoscopic cholecystectomy with postoperative pain and perioperative stress markers :A prospective observational study

Government Institute of Medical Sciences1 site in 1 country85 target enrollmentStarted: August 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
85
Locations
1
Primary Endpoint
To find the association of frailty in elderly patients undergoing Laparoscopic

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
60.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To find the association of frailty in elderly patients undergoing Laparoscopic

Time Frame: 15 mins, 30 ins, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

cholecystectomy under general anaesthesia with post operative pain measured by

Time Frame: 15 mins, 30 ins, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Numeric Rating Scale (NRS) in Post Operative Anaesthesia Care Unit (PACU).

Time Frame: 15 mins, 30 ins, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Secondary Outcomes

  • 1.To find association between frailty and PACU (Post operative anaesthesia care unit)(stay.)

Investigators

Sponsor
Government Institute of Medical Sciences
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Anuradha Sharma

Government Institute of Medical Sciences

Study Sites (1)

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