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Comparing Dexmedetomidine and Fentanyl with Ropivacaine for spinal anaesthesia

Comparison of Dexmedetomidine and Fentanyl as adjuvants to 0.75% hyperbaric Ropivacaine for spinal anaesthesia in orthopaedic lower limb surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058000
Enrollment
120
Registered
2023-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: M849- Disorder of continuity of bone, unspecified Health Condition 2: 7- Osteopathic Health Condition 3: M848- Other disorders of continuity of bone

Interventions

Intervention1: Ropivacaine with dexmedetomidine in spinal anaesthesia: 3ml of 0.75% hyperbaric ropivacaine and 10 mg of dexmedetomidine(0.5ml), administered via intrathecal route,single dose.Effects m

Sponsors

Rajendra institute of medical sciences Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.patients consent 2.ASA physical class 1 and 2 3.elective lower limb orthopaedic surgery cases with duration of surgery not more than 2 hours

Exclusion criteria

Exclusion criteria: 1.patient having contraindication for spinal anesthesia 2.pregnant females 3.patient with chronic disease 4.patient with BMI >30kg/m2 4.patient shorter than 150cms

Design outcomes

Primary

MeasureTime frame
Onset and duration of sensory block in all three groupsTimepoint: From time of induction till T10 level of block achieved for onset(within 30 mins of induction). For duration,from time of induction till patient feels the sensation at S1 dermatome (till 12hrs after induction)

Secondary

MeasureTime frame
maximum sensory blockade attained & time taken for sameTimepoint: 30 -45 mins after induction;onset & duration of motor blockTimepoint: 30mins post induction for onset 12hrs post induction for duration;quality of motor block & time taken for the maximum motor blockadeTimepoint: till 30 mins post induction;time taken for two segment sensory regressionTimepoint: till 12 hrs post induction;total duration of analgesiaTimepoint: till 12hrspost induction

Countries

India

Contacts

Public ContactAmritha sai

Rajendra institute of medical sciences, Ranchi

drpkt80@gmail.com

Outcome results

None listed

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