| CTRI Number |
CTRI/2025/09/094080 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation Of Post-Operative Delirium In Elderly Patients Undergoing Transurethral Resection Of Prostate Surgeries Under Spinal Anaesthsia:An Observational Study |
|
Scientific Title of Study
|
Evaluation Of Post-Operative Delirium In Elderly Patients Undergoing Transurethral Resection Of Prostate Surgeries Under Spinal Anaesthesia: 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 |
Mahesh Pujari |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9632598605 |
| Fax |
|
| Email |
pujarim977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department,Ground Floor ,Sapthagiri Institute of Medical
Sciences and Research Centre,Navy Layout,Hesaraghatta Main
Road ,Chikkabanavara ,Bangalore ,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesiology Ground Floor OT Complex |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Navy Layout, Hesaraghatta Main
Road, Chikkabanavara |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mahesh Pujai |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of
Anaesthesiology
Ground Floor OT
Complex, #15
Hesarghatta Main
Road, Chikkabanavara
Bangalore
KARNATAKA |
9632598605
pujarim977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients willing to participate in evaluation of postoperative delirium undergoing Transurethral resection of prostate under spinal anaesthesia. 2.Age 65 to 99 years.3.American Society of Anaesthesiologists grade I II and III. |
|
| ExclusionCriteria |
| Details |
1.Pre-operative delirium evaluated by CAM. 2.History of acute neurological disorder like stroke,traumatic brain injury in the past 3 months. 3.Serum sodium less than or equal to 130mEq/L |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate post-operative delirium using MMSE (Mini-Mental State Examination) score in
elderly patients undergoing Transurethral Resection of Prostate (TURP) under spinal anaesthsia |
12 hours and 48hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the Confusion Assessment Method (CAM) for detecting post-operative delirium(POD)in patients undergoing TURP surgeries. |
12hours & 48hours |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
15/09/2025 |
| 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 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 - NO
|
|
Brief Summary
|
An observational study assesses the incidence of postoperative delirium (POD) in elderly patients (>65years)undergoing TURP under spinal anesthesia. Delirium is evaluated using the Confusion Assessment Method (CAM) and MMSE(mini mental status examination)at 12 and 48 hours postoperatively, determining the proportion of patients who develop early cognitive disturbances within the first 48 hours. |