| CTRI Number |
CTRI/2024/12/078198 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Dexmedetomidine to Help Prevent altered mental state After Surgery in Older Adults |
|
Scientific Title of Study
|
Low versus standardized bolus dose of dexmedetomidine to prevent post operative delirium in elderly undergoing abdominal surgeries; Non inferiority trial. |
| 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 Bhargav sai |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
PGIMER,Sector 12,madya marg, chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9490335407 |
| Fax |
|
| Email |
bhargavsaiyelika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvir samra |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
PGIMER,Sector 12,madya marg, chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvir samra |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
PGIMER,Sector 12,madya marg, chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research,sector 12, Chandigarh, India.
pin code 160012 |
|
|
Primary Sponsor
|
| Name |
Yelika Bhargav sai |
| Address |
Postgraduate insitute of medical education and research, Sector 12, Madhya marg, Chandigarh, India.
pin code 160012 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Yelika Bhargav Sai |
Postgraduate Institute of Medical Education and Research |
A block Nehru hospital main ot complex and Nehru extension hospital ot,PGIMER,sector 12, madya marg, Chandigarh,India
PIN code 160012
Chandigarh
CHANDIGARH |
9490335407
bhargavsaiyelika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research,Chandigarh,Institutional ethics committee(intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low bolus dose of dexmedetomidine in elderly |
Group LD: Bolus dose of dexmedetomidine administered over 10 minutes will be 0.4mcg/kg followed by continuous infusion at a rate of 0.4mcg/kg/hr until half an hour before end of surgery. |
| Comparator Agent |
standardized bolus dose of dexmedetomidine |
Group SD: Bolus dose of dexmedetomidine administered over 10 minutes will be 0.8mcg/kg followed by continuous infusion at a rate of 0.4mcg/kg/hr until half an hour before end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients giving consent with ASA 1 to 3 |
|
| ExclusionCriteria |
| Details |
Patients with history of chronic kidney disease 4 or 5, Chronic liver disease, pre operative intellectual impairment (mental retardation). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of delirium using short CAM score within first 48 hours after surgery in patients administered a standardised (0.8 µg/kg) versus a low (0.4µg/kg) bolus dose of dexmedetomidine (after induction of anaesthesia followed by a continuous infusion at a rate of 0.4 µg/kg/hr until half hour before the end of surgery. |
RASS followed by short CAM score at post surgery
0hrs
12hrs
24hrs
48hrs
72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative and post operative hemodynamic stability
• Post op pain
• Time to awakening (from stop of volatile agents to eye opening on command)
• Time to extubation |
VAS and RASS score immediately in post operative care unit |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 an acute, fluctuating disturbance of consciousness. It is characterised by impaired awareness and attention and decline in cognitive function. It is not a spot diagnosis; repeated follow up over days is needed for its diagnosis. Delirium is sub-classified into 3 types; hyperactive, hypoactive and/or mixed on the basis of the psychomotor features. Overall incidence of post operative delirium in patients undergoing non cardiac surgeries has been reported as 50%. Advanced age has been recognised as one of the risk factors for POD.3 It is estimated that 80% of geriatric patients scheduled for surgery develop POD. In view of this high incidence, recently, a lot of research has been carried out to investigate the risk factors and pharmacological agents which can be used to prevent POD in this subset of patients. Various pharmacological agents have been used to decrease incidence of POD in elderly.Antipsychotics, statins, melatonin, dexamethasone, gabapentin, diazepam are some of the drugs which have been used.13 Dexmedetomidine a selective alpha-2-adrenergic receptor agonist. It is thoroughly used in various stages of the peri anaesthetic period for sedation, decreasing anxiety and for its anti-sympathetic effects.Dexmedetomidine decreases opioid requirements, synergizes normal sleep wake cycles and acts as an anti- inflammatory agent by activating alpha 2 receptors and stimulating the vagus via a receptor dependent mechanism. All patients eligible for study will undergo routine pre anaesthetic evaluation including a detailed history through general physical and systemic examination with relevant baseline investigations (hemogram, coagulation profile, RFTs, ECG and chest x-ray).Pre operative assessment for any cognitive decline in elderly patients will be noted by short IQCODE.43Preoperative CAM and RASS scores will be recorded along with MMSE to rule out any pre-existing cognitive dysfunctions. Dexmedetomidine will be started after induction as per group allocation. After endotracheal intubation, maintenance of anaesthesia will be done with O2/Air and inhalational anaesthetic isoflurane. Dexmedetomidine bolus dose will be administered over 10 minutes and this will be followed by a maintenance dose Scales used for assessment of delirium will be RASS followed by CAM score. If there is presence of delirium the severity of delirium will be assessed by DRS-98 scale. Any patient with RASS of -3 to +4, will be assessed by the CAM in postoperative period at 12 hours (CAM12), 24 hours (CAM24), 48 hours (CAM48) and 72 hours (CAM72). Data for patients whose RASS is -4/-5 will also be collected because they are the ones at maximum risk and will be reassessed to ascertain level of sedation and CAM will be applied whenever feasible |