| CTRI Number |
CTRI/2025/03/083309 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Preventing post-surgery confusion by comparing two approaches using dexmedetomidine and melatonin |
|
Scientific Title of Study
|
To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing postoperative delirium in elderly patients undergoing cardiac surgery -A prospective randomised interventional 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 Haritha Ravindran |
| Designation |
Senior Resident |
| Affiliation |
Sree chitra tirunal institute for medical sciences and technology |
| Address |
Department of cardiac anesthesia, Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7708190480 |
| Fax |
|
| Email |
hari7ravindran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneel P R |
| Designation |
Professor |
| Affiliation |
Sree chitra tirunal institute for medical sciences and technology |
| Address |
Department of cardiac anesthesia Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7708190480 |
| Fax |
|
| Email |
suneel@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haritha Ravindran |
| Designation |
Senior Resident |
| Affiliation |
Sree chitra tirunal institute for medical sciences and technology |
| Address |
Department of cardiac anesthesia
Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7708190480 |
| Fax |
|
| Email |
hari7ravindran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
Kerala 695011 |
|
|
Primary Sponsor
|
| Name |
Sree chitra tirunal institute for medical sciences and technology |
| Address |
Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
Kerala 695011 |
| 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 Haritha Ravindran |
Sree chitra tirunal institute for medical sciences and technology |
Cardiac surgery intensive care unit
Sree chitra tirunal institute for medical sciences and technology
Thiruvananthapuram
KERALA |
07708190480
hari7ravindran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY,TRIVANDRUM,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj.Dexmedetomidine alone |
Inj Dexmedetomidine is started intraoperatively at 0.025-0.05mcg/kg/min in both the study groups and continued for 3 days, post operative day 0, 1 and 2. |
| Intervention |
T.Melatonin |
T.Melatonin along with Inj. Dexmedetomidine is used in preventing delirium.T. Melatonin 6mg is given the night before surgery and continued for 3 days, post operative day 0, 1 and 2. Inj Dexmedetomidine is started intraoperatively at 0.025-0.05mcg/kg/min and continued for 3 days,post operative day 0, 1 and 2. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 60 years
2.Patients scheduled for elective cardiac surgery
|
|
| ExclusionCriteria |
| Details |
1.Patient with current/past history of mental illness, neuropsychiatric disease, h/o substance abuse, alcohol dependence.
2.History of known allergy to the study drugs.
3.Patients who had taken drugs which may cause sedation in last 12hours.
4.History of intake of antiepileptics, antianxiety drugs, hypnotics, antidepressants or antipsychotics.
5.H/o OSA and diagnosed sleep disorders.
6.Redo-surgeries.
7.Hemodynamically unstable patients.
8.Patients refusing consent for study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing incidence of postoperative delirium in elderly patients undergoing cardiac surgery and to identify the agent that provides superior delirium prevention outcomes. |
Delirium will be assessed using Confusion assessment method for the ICU (CAM-ICU) one day before surgery and on postoperative day 0, 1 and 2. Postoperative delirium will be defined by fulfilment of the CAM-ICU criteria which includes 1) acute onset and fluctuating symptoms, 2) inattention, and either 3) an altered level of consciousness or 4) disorganised thinking |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the differences in the duration of delirium between patients receiving dexmedetomidine with melatonin & dexmedetomidine alone.
2.To compare duration of mechanical ventilation & ICU stay between two groups.
3.To compare sleep disturbance, cognitive dysfunction & sedation level among both the groups.
4.To compare the total requirement of haloperidol drug in both groups.
|
Postoperative agitation will be noted based on Ramsay Sedation Score on the pre operative day,postoperative day 0, 1 & 2. Post Operative Cognitive Dysfunction will be defined as a reduction in MMSE score less than 23, noted on pre operative day, post op day 0,1 & 2. Any requirement of sedatives like midazolam, antipsychotics like haloperidol in the postoperative period on day 0, 1 & 2 shall be noted. Duration of mechanical ventilation, length of ICU stay shall also be noted. |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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 4 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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
|
Delirium is a brain dysfunction characterized by an acute onset and fluctuating disturbance in consciousness,
attention and cognition. Postoperative delirium (POD) is a neuropsychiatric
syndrome characterized by disturbances of cognition, attention, consciousness,
or perception with acute onset and
fluctuating course.The incidence of POD in older individuals is
15% to 53%, most frequently occurring in the first 3 days after
the procedure.Postoperative delirium (POD) is associated with poor
outcomes, including prolonged hospital stay, increased costs, and worsened
quality of life. Current interventions for delirium prevention primarily involve
recognition and improvement of modifiable
risk factors besides active treatment of original diseases, but the curative
effect is not obvious. Within current guidelines, no pharmacological methods
were recommended for delirium prevention. After cardiac surgery, delirium remains the most common neurocognitive
complication with an incidence of 6-46% .
Patients who have cardiac surgery are at higher risk of postoperative delirium
than those following noncardiac surgery because of a higher prevalence of risk
factors, such as older age, cerebrovascular disease, diabetes mellitus, and
renal disease and receipt of cardiopulmonary bypass. Dexmedetomidine and melatonin have both shown promise in preventing
delirium in various patient populations. However, there is a lack of
comparative studies evaluating the efficacy of these two agents in cardiac
surgery patients. This research proposal outlines a comparative study between
dexmedetomidine and melatonin in preventing postoperative delirium in cardiac
surgery patients. |