To compare efficacy and effectiveness of intrathecal dexmedetomidine versus intrathecal fentanyl as an additive to Isobaric Levobupivacaine in patients undergoing elective Lower Limb Orthopedic surgeries.

A randomized study to compare the Efficacy and Safety of Intrathecal Dexmedetomidine versus Fentanyl as an adjuvant to Isobaric Levobupivacaine for Elective Lower Limb Orthopaedic Surgery. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085839

Enrollment

Registered

2025-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Spinal Anaesthesia in Lower limb surgeries: To compare the Efficacy and Safety of Intrathecal 5 mcg(0.5 ml) preservative free Dexmedetomidine versus Intrathecal 25mcg(0.5ml) preservativ

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who will give informed written consent. 2.Patients belonging to ASA Class I and II. 3.Patients 18 60 years of age of either sex. 4.Patients Height 150-180 cm. 5.Patients Weight 50-80 kg.

Exclusion criteria

Exclusion criteria: 1.Patients having allergy to study drugs. 2.Patient should not be a part of other study. 3.Non co-operative patients. 4.Patients having absolute contraindications to spinal anaesthesia 5.Patients with Heart disease, Uncontrolled Diabetes mellitus, Morbid obesity, Coagulation Abnormalities and Vertebral deformities 6.Patients using alpha 2-adrenergic receptors antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitor.

Design outcomes

Primary

Measure	Time frame
1.Onset of sensory block 2.Onset of motor block 3.Duration of sensory blocks 4.Duration of motor block 5.To achieve Maximum sensory blockTimepoint: 1. 0 min 2. 01 min 3. 02 min 4. 03 min 5. 05 min 6. 10 min 7. 15 min 8. 30 min 9. 45 min 10. 60 min 11. 75 min 12. 90 min	—

Secondary

Measure	Time frame
Hemodynamic changes ( SBP, DBP, MAP, HR, SPO2, RR) and adverse effects associated with drugs under studyTimepoint: 1. 0 min 2. 01 min 3. 02 min 4. 03 min 5. 05 min 6. 10 min 7. 15 min 8. 30 min 9. 45 min 10. 60 min 11. 75 min 12. 90 min	—

Countries

India

Contacts

Public ContactDr Sunil Darwal

Sawai Man Singh Medical College

dr.shriphal@gmail.com9928350391

Outcome results

None listed

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