| CTRI Number |
CTRI/2025/08/093908 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of delirium post- cardiac surgery: Comparison of Quietapine Versus Melatonin |
|
Scientific Title of Study
|
Prospective randomized controlled study for the management of delirium post- cardiac surgery: comparison of Quietapine Vs Melatonin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chanchal Bhandari |
| Designation |
Assistant Professor (Cardiac Anesthesia)) |
| Affiliation |
B.J. Medical College, Ahmedabad |
| Address |
Department of Cardiac Anesthesia, UNMICRC, Civil hospital campus, Asarwa,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9404552355 |
| Fax |
|
| Email |
honeypanwad287@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chanchal Bhandari |
| Designation |
Assistant Professor (Cardiac Anesthesia)) |
| Affiliation |
B.J. Medical College, Ahmedabad |
| Address |
Department of Cardiac Anesthesia, UNMICRC, Civil hospital campus, Asarwa,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9404552355 |
| Fax |
|
| Email |
honeypanwad287@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chanchal Bhandari |
| Designation |
Assistant Professor (Cardiac Anesthesia)) |
| Affiliation |
B.J. Medical College, Ahmedabad |
| Address |
Department of Cardiac Anesthesia, UNMICRC, Civil hospital campus, Asarwa,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9404552355 |
| Fax |
|
| Email |
honeypanwad287@gmail.com |
|
|
Source of Monetary or Material Support
|
| U N Mehta Institute of Cardiology and Research Centre (UNMICRC) |
|
|
Primary Sponsor
|
| Name |
U N Mehta Institute of Cardiology and Research Centre UNMICRC |
| Address |
U N Mehta Institute of Cardiology and Research Centre (UNMICRC), Asarwa, Ahmedabad, Gujarat, India |
| 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 |
| Dr Chanchal Bhandari |
UNMICRC Ahmedabad |
civil Hospital campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT |
9404552355
honeypanwad287@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee UNMICRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group M : Tab. Melatonin |
Group M : Tablet, Melatonin 5 mg (twice a day till delirium subsides) |
| Intervention |
Group Q: Tab. Quietapine
|
Group Q: Tablet, Quietapine 25 mg (twice a day till delirium subsides)
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All elective cardiac surgeries who developed delirium in ICU |
|
| ExclusionCriteria |
| Details |
Patient not on any antipsychotic medications
No prior history of psychiatric illness
No history of neurological disease or stroke / TIA
No history of delirium prior to surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the efficacy of Quietapine vs Melatonin in treatment of delirium post- cardiac surgery in the cardiac intensive care unit |
baseline and every 8th hourly in ICU till post operative day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe length of ICU stay, postoperative complications & mortality & morbidity of patients |
baseline & every 8th hourly in ICU till post operative day 7 |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
Modification(s)
|
Written informed consent will be obtained from the study population who will be eligible in terms of inclusion and exclusion criteria before participating in the study Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study Preoperative cognition will be assessed Written and informed consent will be taken from the patient prior to the surgery Patient education, comorbidities like hypertension, diabetes, preoperative hemoglobin levels, EUROSCORE II will be noted After extubation patient will be assessed by the confusion assessment method for the ICU CAM score Patients with delirium will be randomized into 2 groups Group Q Tab Quietapine 25 mg BD will be started Group M Tab Melatonin 5 mg BD will be started Patient will not be given any benzodiazepines during that period The CAM ICU score will be assessed every eighth hour during ICU stay and score will be noted for 7 days Comparative analysis will be done whether delirium has decreased or not. Total duration of ICU stay of the patient will be noted If patients delirium not improved then psychiatric reference will be done and treatment will be given accordingly |