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A comparative study of spinal levobupivacaine and dexmedetomidine verses spinal levobupivacaine and magnesium sulphate in Lower Limb Orthopaedic Surgery â??A prospective randomized double blind clinical trialâ??.

A Comparative study of Intrathecal Levobupivacaine and Dexmedetomidine verses intrathecal Levobupivacaine and Magnesium Sulphate in Lower Limb Orthopaedic Surgery â??A prospective Randomized double blind clinical trialâ??.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053553
Enrollment
90
Registered
2023-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine is a selective 뱉??2 receptor agonist and 7X more selective in comparison to clonidine and has similar mechanism of blocking hyperpolarisation activate
however, it is often associated with higher incidence of bradycardia. Intervention2: Magnesium Sulphate: Magnesium Sulphate is a non-competitive antagonist of the Nâ??methylâ??dâ??aspartate (NMDA) rec

Sponsors

SELF
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18 to 60 years. 2. Patients with ASA physical status 1 & 2. 3. Patients willing to participate. 4. Lower limb Orthopaedic procedure requiring spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients refusal to participate. 2. Patients age 60 years. 3. ASA physical status 3 or higher. 4. Any contraindication to spinal Anaesthesia. 5. Patient with known allergy to any of the study drugs and cardiac conduction defects, renal or hepatic impairment.

Design outcomes

Primary

MeasureTime frame
To compare the effects of quality of anaesthesia duration between dexmedetomidine and magnesium sulphate in combination with levobupivacaine in lower limb surgeries.Timepoint: 2 yrs—

Secondary

MeasureTime frame
â?¢ Onset of block. â?¢ Intra-operative hemodynamic changes. â?¢ Nausea, Vomiting. â?¢ Any other complication. â?¢ Use of Atropine and Mephentermine. Timepoint: 2 yrs—

Countries

India

Contacts

Public ContactKamal Kant Agrawal

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES

drvvinodv@gmail.com8292000111

Outcome results

None listed

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