A Study to Assess Temporary Confusion After Orthopedic Lower Limb Surgery in Older Adults Receiving Sedation During Spinal Anesthesia

Postoperative Delirium after Dexmedetomidine Sedation in Healthy Older Adults Undergoing Orthopedic Lower Limb Surgery with Spinal Anesthesia: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100452

Enrollment

120

Registered

2026-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: W108- Fall (on) (from) other stairs andsteps Health Condition 2: C402- Malignant neoplasm of long bones of lower limb Health Condition 3: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere Health Condition 4: V00-V09- Pedestrian injured in transport accident Health Condition 5: L762- Postprocedural hemorrhage of skinand subcutaneous tissue following a procedure Health Condition 6: S722- Subtrochanteric fracture of femur Health Condi

Interventions

Intervention1: IV sedation with Dexmedetomidine after Spinal anaesthesia: Assessment of postoperative delirium after iv sedation with Dexmedetomidine following spinal anaesthesia in elderly patient

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the proportion of patients experiencing delirium as per the Confusion Assessment Method (CAM) delirium scaleTimepoint: Upto 72-hour post operatively	—

Secondary

Measure	Time frame
Secondary outcomes will include the mean arterial pressure(MAP), heart rate(HR), duration of block and other adverse effects, if anyTimepoint: Recorded at every 2 mins for the first 10 mins then every 10 mins from thereon till 60 mins	—

Countries

India

Contacts

Public ContactDr Niharika Sharma

RNT Medical College Udaipur

vbedimd@gmail.com9829025373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026