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.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/04/085839
• Lead Sponsor: Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur

Brief Summary

Spinal anaesthesia is the most commonly used technique for lower limb orthopaedic surgeries as it is very economical and easy to administer. This is due to the factors like avoiding the risks of general anesthesia such as pulmonary aspiration, bronchospasm, laryngospasm, cardiovascular response to intubation or risk of failed intubation and also allowing a patient to remain awake and enjoy the Painless experience of surgery. It also provides effective pain relief during intra operative and early postoperative period. Spinal anaesthesia also has rapid onset and low failure rate.



Spinal anesthesia is performed by placing a needle between the lumbar vertebrae and through the dura to inject anesthetic medication. Levobupivacaine, a new local anaesthetic, has been recently introduced into clinical practice because of its lower toxic effects for heart and central nervous system. Administrating the combinations of other classes of analgesics with local anesthetics has used to increase the duration and reduce side effects of analgesia. Some drugs have been used as adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia including opioids (morphine, fentanyl and sufentanyl to hydromorphone, buprenorphine and tramadol), alpha2 agonists, neostigmine, vasoconstrictors, etc. Clonidine and dexmedetomidine are two alpha2 agonists affecting via pre- and post-synaptic alpha2 receptors.



For this a total of 60 patients (n = 60) undergoing lower limb orthopaedic surgeries will be randomly divided into two groups ( Group A and Group B). Group A patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Dexmedetomidine 5mcg and Group B patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Fentanyl 25mcg to subarachnoid block.



Patient will be received in operation theatre, intravenous cannula will be secured and hemodynamic variables will be noted. Surgery will be started after T10 level sensory blockade will achieve. Quantitative values of time of onset and duration of sensory and motor blockade, time taken to achieve maximum sensory blockade will be recorded.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-11-05
• Study Start: 2025-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Patients who will give informed written consent.
• 2.Patients belonging to ASA Class I and II.
• 4.Patients Height 150-180 cm.
• 5.Patients Weight 50-80 kg.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Onset of sensory block	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
2.Onset of motor block	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
5.To achieve Maximum sensory block	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
3.Duration of sensory blocks	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
4.Duration of motor block	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 Outcome Measures

Name	Time	Method
Hemodynamic changes ( SBP, DBP, MAP, HR, SPO2, RR) and adverse effects associated with drugs under study	1. 0 min

Trial Locations

Locations (1)

Sawai Man Singh Medical College and Attached Hospital Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Sawai Man Singh Medical College and Attached Hospital Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Shriphal Meena

Principal investigator

9928350391

dr.shriphal@gmail.com