Comparison Of A Drug Dexmedetomidine by Two Different Route Intravenous or Intrathecal With Ropivacaine Heavy in Spinal Block for Lower Limb Orthopaedic Surgery

Intravenous Versus Intrathecal Dexmedetomidine As an Adjuvant to 0.75% Hyperbaric Ropivacaine in Spinal Anaesthesia for Lower Limb Orthopaedic Surgery -A Randomized Double Blind Comparative study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089076

Enrollment

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: S724- Fracture of lower end of femur Health Condition 2: S821- Fracture of upper end of tibia Health Condition 3: S822- Fracture of shaft of tibia Health Condition 4: S823- Fracture of lower end of tibia Health Condition 5: S723- Fracture of shaft of femur

Interventions

Intervention1: Spinal Anaesthesia: Duration of Analgesia is compared between Hyperbaric Ropivacaine 0.75 percentage(18.75mg)with intrathecal (5mcg) or intravenous (5mcg per kg) Dexmedetomidine in spin

Eligibility

Inclusion criteria

Inclusion criteria: Patient with ASA physical status Grade I and II Patient undergoing elective surgery under spinal anaesthesia Patient with Mallampati Class I and II

Exclusion criteria

Exclusion criteria: Pregnant patients. Patients having coagulation abnormalities, platelet count less than 75000, INR more than 1.5, or on anticoagulants. Patients having systemic illness (severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic, valvular,congenital heart diseases, psychiatric, hematological disorder). Patients having any absolute contraindications for spinal anesthesia. Patient refusal to participate in study. Any allergy to study drugs or local anaesthetic drugs. Short stature (height less then 150cms) Patients with spinal deformity. Patients with BMI more than 30.

Design outcomes

Primary

Measure	Time frame
Evaluate and Compare the Duration of Analgesia. Timepoint: 0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour	—

Secondary

Measure	Time frame
Onset and duration of sensory block Onset and duration of motor block Peak sensory level achieved Time to reach peak sensory level Maximum Bromage score achieved Consumption of rescue analgesic drug in 24 hours post operatively Sedation Score Haemodynamic parameters Adverse effects, if anyTimepoint: 0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour	—

Measure

Time frame

Onset and duration of sensory block Onset and duration of motor block Peak sensory level achieved Time to reach peak sensory level Maximum Bromage score achieved Consumption of rescue analgesic drug in 24 hours post operatively Sedation Score Haemodynamic parameters Adverse effects, if anyTimepoint: 0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour

—

Countries

India

Contacts

Public ContactDr Anuradha Vyas

R.N.T Medical College

sharma0979@yahoo.co.in09214323557

Outcome results

None listed

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