| CTRI Number |
CTRI/2026/01/100452 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess Temporary Confusion After Orthopedic Lower Limb Surgery in Older Adults Receiving Sedation During Spinal Anesthesia |
|
Scientific Title of Study
|
Postoperative Delirium after Dexmedetomidine Sedation in Healthy Older Adults Undergoing Orthopedic Lower Limb Surgery with Spinal Anesthesia: A Randomized Controlled 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 Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College and Hospital ,Udaipur |
| Address |
Emergency OT, Department of Anaesthesiology, RNT Medical College and Hospital, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Emergency OT, Department of Anaesthesiology, RNT Medical College and Hospital, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niharika Sharma |
| Designation |
PG Resident |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia, RNT Medical College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7073739162 |
| Fax |
|
| Email |
neharikasharma.ns11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, RNT Medical College and Hospital, Udaipur |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Goverment Hospital |
| Address |
Department of Anaesthesiology,RNT Medical College and Hospital, Udaipur Rajasthan, India , 313001 |
| Type of Sponsor |
Government 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 Vikram Bedi |
Maharana Bhupal Government Hospital |
Orthopedic OT, Second floor, Trauma Centre, Maharana Bhupal Government Hospital, Udaipur
Udaipur
RAJASTHAN |
9829025373
vbedimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT Medical College and Controller and attached hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W108||Fall (on) (from) other stairs andsteps, (2) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (3) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, (4) ICD-10 Condition: V00-V09||Pedestrian injured in transport accident, (5) ICD-10 Condition: L762||Postprocedural hemorrhage of skinand subcutaneous tissue following a procedure, (6) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (7) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (8) ICD-10 Condition: M217||Unequal limb length (acquired), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV sedation with Dexmedetomidine after Spinal anaesthesia |
Assessment of postoperative delirium after iv sedation with Dexmedetomidine following spinal anaesthesia in elderly patient undergoing lower limb orthopaedic surgery |
| Comparator Agent |
Placebo with IV normal saline |
Placebo with iv normal saline 100 ml infusion through the surgery, stopped just before skin suturing |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group:- Elderly patients, aged 60 year or older
2. Patients who will be scheduled for elective lower extremity orthopedic surgery with spinal anesthesia.
3. ASA Status:- grade I and II |
|
| ExclusionCriteria |
| Details |
1. Patient allergic to study drug
2. Patients with visual, cognitive, language, or speech impairment, neuropsychiatric diseases including dementia, Parkinson’s disease, or cerebrovascular accidents were excluded. |
|
|
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 |
| The primary outcome will be the proportion of patients experiencing delirium as per the Confusion Assessment Method (CAM) delirium scale |
Upto 72-hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will include the mean arterial pressure(MAP), heart rate(HR), duration of block and other adverse effects, if any |
Recorded at every 2 mins
for the first 10 mins then every 10 mins from thereon till 60 mins |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/01/2026 |
| 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="0"
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
|
We would like to compare intravenous dexmedetomidine and placebo for incidence of postoperative delirium following spinal anaesthesia for lower limb orthopedic surgery in elderly in term of confusion assessment score(CAM) Ramsay sedation score, hemodynamic parameters, other adverse outcome if any. Kindly grant CTRI registration for our study as dexmedetomidine is FDA approved drug. |