| CTRI Number |
CTRI/2026/03/107067 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
study the incidence of post-operative confusion state |
|
Scientific Title of Study
|
Evaluation of Postoperative Delirium Using the 4AT TEST: Determining Incidence and Risk Factors in Patients Undergoing General Anaesthesia |
| 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 Nirali Paanchal |
| Designation |
Professional of department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirali Paanchal |
| Designation |
Professional of department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krunal Prajapati |
| Designation |
1st year Resident |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat
Anand
GUJARAT
388325
India |
| Phone |
8530665636 |
| Fax |
|
| Email |
krunalhimans143@gmail.com |
|
|
Source of Monetary or Material Support
|
| shree krishna hospital, pramukhswami medical college, Karamsad, Anand, Gujarat, India,388325 |
|
|
Primary Sponsor
|
| Name |
SHREE KRISHNA HOSPITAL AND PRAMUKH SWAMI MEDICAL COLLEGE KARAMSAD ANAND INDIA |
| Address |
Shree Krishna hospital,Pramukh swami medical college, Karamsad,Anand, Gujarat,India,388325 |
| Type of Sponsor |
Private 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 Nirali Panchal |
Pramukh Swami medical college,shree Krishna Hospital,Karam sad,Anand |
Department of
Anesthesiology,Surgical
operation theater
complex
Anand
GUJARAT |
9825031808
dr.niralipanchal@gmail. com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand,Gujarat- 388325 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist (ASA) Grade 1 to 3
Adults aged more than equal to 40 years.
Patients undergoing surgery with general anaesthesia.
Patients who are haemodynamically stable in the PACU.
|
|
| ExclusionCriteria |
| Details |
Post op patient unreversed directly shifted to icu
Patients who are taking Certain medications such as benzodiazepines, anticholinergics, high-dose opioids, corticosteroids, and centrally acting drugs
Active delirium or altered mental status pre-operatively (diagnosed before surgery)
Known psychiatric disorders with psychotic features requiring antipsychotic medications
Severe dementia (inability to provide informed consent or complete baseline assessment)
Current substance abuse or withdrawal states
Patients on therapeutic sedation/mechanical ventilation pre-operatively
Patients with pre-existing diagnosis of delirium or severe dementia.
Patients with severe neurological deficits or communication barriers (e.g., aphasia, severe hearing impairment).
Patients who refuse to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of postoperative delirium using the 4AT test in patients undergoing surgery with general anaesthesia. |
At post anaesthesia care unit, at 12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the Risk factors for post operative delirium after general anaesthesia |
At post anaesthesia care unit, at 12 & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/04/2026 |
| 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
|
Postoperative delirium is a common yet under-recognized complication following surgery under general anaesthesia, associated with increased morbidity, prolonged hospital stay, and adverse outcomes. This prospective observational study aims to determine the incidence of postoperative delirium using the validated 4AT (4 A’s Test) and to identify perioperative risk factors in adults aged more than equal to 40 years. The study will be conducted at Shree Krishna Hospital. Delirium assessment will be performed in the post-anaesthesia care unit and at 12 and 24 hours postoperatively. Early identification of delirium may facilitate timely intervention and improve postoperative care and outcomes. |