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A clinical comparative study of dexmedetomidine versus fentanyl versus buprenorphine as adjuvants to intrathecal bupivacaine in lower limb surgeries

A clinical comparative study of dexmedetomidine , fentanyl , buprenorphine as adjuvants to intrathecal bupivacaine in lower limb surgeries - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094503
Enrollment
120
Registered
2025-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 2: M15-M19- Osteoarthritis Health Condition 3: M84- Disorder of continuity of bone

Interventions

Intervention1: Bupivacaine heavy 15mg with Buprenorphine 60mcg: Bupivacaine heavy 15mg and buprenorphine 60 mcg given in sub arachnoid block for lower limb surgeries Control Intervention1: Bupivacaine

Sponsors

Dr Subhajyoti konar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 60 yrs , male and female . 2. Patients of American Society of Anaesthesiologists physical status class 1 and class 2. 3. Patients scheduled for elective lower limb surgeries.

Exclusion criteria

Exclusion criteria: 1. BMI more than 35 kg per meter square 2. Patients with bleeding disorders or patients on anticoagulant therapy 3. Patients with history of cardiac disorders or are on beta blockers or alpha antagonists . 4. Any allergy to test drug 5. Pregnancy and lactation 6.Patients with chronic pain on slow-release preparations of opioid, drug abuse or chronic alcohol use . 7. Patients with dementia or cognitive problems. 8. Any contraindications to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To note the time duration of sensory and motor block of the intervention and 2 comparator agentsTimepoint: Intraoperative and postoperative

Secondary

MeasureTime frame
To note the adverse effects like bradycardia , hypotension , nausea , vomiting , itching , respiratory depression , desaturationTimepoint: Intraoperative;To assess the duration of postoperative analgesiaTimepoint: Postoperative;To monitor heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure , oxygen saturationTimepoint: Intraoperative

Countries

India

Contacts

Public ContactDr reshma B M

DR. B R Ambedkar medical college and hospital

lucky3276@gmail.com8892019120

Outcome results

None listed

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