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AN OBSERVATIONAL STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH DEXMEDATOMEDINE 10 MICROGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH NALBUPHINE 1 MG IN LOWER LIMB ORTHOPAEDIC SURGERIES

AN OBSERVATIONAL STUDY OF COMPARISION BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH DEXMEDATOMEDINE 10Mcg VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH NALBUPHINE 1 mg IN LOWER LIMB ORTHOPAEDIC SURGERIES - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076686
Enrollment
60
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: M160- Bilateral primary osteoarthritis of hip Health Condition 2: M170- Bilateral primary osteoarthritis of knee Health Condition 3: M864- Chronic osteomyelitis with draining sinus

Interventions

Intervention1: inj. dexmedatomedine 10 mcg intracthecally with hyperbaric bupivacaine : inj. dexmedatomedine 10 mcg intrathecally as an additive to inj. bupivcaine hyperbaric to compare the hemodynami

Sponsors

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to sign the informed written consent. Patients of ASA Grade I and II of either gender. Under Spinal anaesthesia for elective pelvic and lower limb surgeries Aged 20 - 60 years. No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.

Exclusion criteria

Exclusion criteria: Patient refusal. ? Patient not NIL by mouth. ? History of seizure disorder. ? Known allergy to trial drugs. ? Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction. ? ASA III, IV, V Patients. ? Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases, known fetal abnormalities) ? Pregnant females ? Failed spinal anesthesia converted to general anesthesia ? Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.

Design outcomes

Primary

MeasureTime frame
to Compare efficacy of dexmedatomedine and nalbuphine in blunting hemodynamic response and post operative analesgia in patient recieving Spinal anaesthesia in lower limb orthopedic surgeriesTimepoint: Baseline 0 min 2 mins 5 mins 10 mins 15 mins 20 mins 30 mins 45 mins 60 mins 75 mins 90 mins 120 mins 150 mins 180 mins—

Secondary

MeasureTime frame
to compare duration of post operative analgesia in group dexmedatomedine and group nalbuphineTimepoint: time at which rescue analgesia was given.—

Countries

India

Contacts

Public ContactKartik H Sangam

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre

sangam2494@gmail.com8767272524

Outcome results

None listed

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