Calculation of dose of a drug (hyperbaric Ropivacaine) with or without an adjuvant (Dexmedetomidine) for fracture of thigh bone

Comparison of the ED50 of intrathecal hyperbaric Ropivacaine co-administered with or without Dexmedetomidine for femoral nailing:A prospective,double-blind,randomised dose- response trial using up-down sequential allocated method - NIll

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056984

Enrollment

Registered

2023-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: 7- Osteopathic Health Condition 2: S722- Subtrochanteric fracture of femur Health Condition 3: S722- Subtrochanteric fracture of femur

Interventions

Control Intervention1: Inj-Dexmedetomidine: 5 microgram INTRATHECAL DEXMEDTOMIDNE AND OBSEVATION WILL BE DONE 20 MIN AFTER SUBARCHNOID BLOCK Control Intervention2: Inj-Hyperbaric Ropivacaine in subara

Eligibility

Inclusion criteria

Inclusion criteria: This study will carried out for patients scheduled for elective nailing for fracture femur with ASA grade 1 and 2 with aged 18-80 years on estimated surgery time 1to 3 hours under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1-patient refusal 2-patient allergic to study drug 3-patient with fixed cardiac output states 4-patient who are already on alpha 2 receptor agonist 5-HR <50/min

Design outcomes

Primary

Measure	Time frame
To evaluate ED50 of intrathecal hyperbaric Ropivacaine with or without Dexmedetomidine for femoral nailingTimepoint: Intraoperatively (1 to 3 hours)	—

Secondary

Measure	Time frame
To determine the adverse effectsTimepoint: Post operatively upto 24 hours	—

Countries

India

Contacts

Public ContactDeepanshu Sondhi

Rnt medical college , udaipur , Rajasthan

Vbedimd@gmail.com9829025373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026