To compare the effect of two different drugs added to local anaesthetic drug given for spinal anaesthesia in patients undergoing orthopedic lower limb surgeries

Comparison of intrathecal Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine in orthopedic lower limb surgeries- A double blind randomized control study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036529

Enrollment

Registered

2021-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: S90-S99- Injuries to the ankle and foot Health Condition 2: S70-S79- Injuries to the hip and thigh Health Condition 3: S80-S89- Injuries to the knee and lower leg

Interventions

Intervention1: Dexmedetomidine: 5 micrograms added intrathecally to 2.5 ml 0.5% Hyperbaric Bupivacaine Control Intervention1: Fentanyl: 25 micrograms added intrathecally to 2.5ml 0.5% Hyperbaric Bupiv

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA physical status 1 and 2 Patients giving informed valid written consent Patients undergoing elective orthopedic lower limb surgeries under spinal anaesthesia

Exclusion criteria

Exclusion criteria: Patients posted for emergency surgeries Patients having uncontrolled hypertension or diabetes mellitus Patients with renal or hepatic failure, cardiac block or dysrhythmia, coagulopathies, neurologic disorders Patients having hypersensitivity to any of the study groups Patients with known contraindications to spinal anaesthesia

Design outcomes

Primary

Measure	Time frame
To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeriesTimepoint: after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0	—

Measure

Time frame

To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeriesTimepoint: after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0

—

Secondary

Measure	Time frame
to compare characteristics of block between 2 groups in view of 1.time from injection to highest sensory level 2.onset to bromage 3 3.time for sensory regression to S1 from higher sensory level 4. regression to bromage 0 5.time to rescue analgesia 6.numeric rating scale 6hrs after surgery 7.any adverse effectsTimepoint: after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0, then after 6 hour asses about numeric rating scale	—

Measure

Time frame

to compare characteristics of block between 2 groups in view of 1.time from injection to highest sensory level 2.onset to bromage 3 3.time for sensory regression to S1 from higher sensory level 4. regression to bromage 0 5.time to rescue analgesia 6.numeric rating scale 6hrs after surgery 7.any adverse effectsTimepoint: after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0, then after 6 hour asses about numeric rating scale

—

Countries

India

Contacts

Public ContactDr Sushma K S

Karnataka Institute of Medical Sciences, Hubballi

dr.sushsam@gmail.com9844310403

Outcome results

None listed

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