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Comparison of intrathecal hyperbaric bupivacaine with fentanyl versus intrathecal hyperbaric bupivacaine with dexmedetomidine given sequentially in lower limb orthopaedic surgeries

Comparison of intrathecal hyperbaric bupivacaine with fentanyl versus intrathecal hyperbaric bupivacaine with dexmedetomidine given sequentially in lower limb orthopaedic surgeries - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066585
Enrollment
60
Registered
2024-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: S720- Fracture of head and neck of femur Health Condition 2: S724- Fracture of lower end of femur Health Condition 3: S923- Fracture of metatarsal bone(s) Health Condition 4: S723- Fracture of shaft of femur Health Condition 5: S822- Fracture of shaft of tibia Health Condition 6: S891- Physeal fracture of lower end of tibia Health Condition 7: S890- Physeal fracture of upper end of tibia Health Condition 8: S881- Traumatic amputation at level between knee and ankle Health Con

Interventions

Intervention1: Intrathecal hyperbaric bupivacaine with fentanyl given sequentially in lower limb orthopaedic surgeries: Vital monitoring devices will be attached to the patient.Under all aseptic preca

Sponsors

Uttar Pradesh university of medical sciences Saifai Etawah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age more than 18 years of both gender undergoing lower limb orthopaedic surgeries

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Neuropsychiatric disorder or on chronic use of psychoactive medications 3. Hepatic and renal impairment 4. History of epilepsy 5. Cardiac block or dysrhythmias 6. Uncontrolled hypertension or diabetes mellitus 7. Coagulation abnormality 8. Allergy to any study drug 9. Known contraindication to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To evaluate the intraoperative and postoperative hemodynamic stabilityTimepoint: Upto 24 hours

Secondary

MeasureTime frame
To find and compare the onset of sensory block with sensation to pin prick, motor block by Modified Bromage scale,block regression times,duration of postoperative analgesia provided by adjuvantsTimepoint: Upto 24 hours

Countries

India

Contacts

Public ContactDR.KRITI MISHRA

UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES AND RESEARCH SAIFAI ETAWAH

ushashukla1970@gmail.com9412201915

Outcome results

None listed

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