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checking the difference between the drugs Fentanyl and Dexmedetomidine by giving in spinal canal by adding to Bupivacaine heavy in lower Limb orthopedic surgery

Comparative study of Intrathecal Fentanyl and Dexmedetomidine as adjuvant to hyperbaric Bupivacaine in lower Limb Orthopedic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015635
Enrollment
64
Registered
2018-09-06
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: null- 1. American Society of Anaesthesiologists(ASA) physical status I or II. 2. Either sex (Male/Female). 3. Age between 18-55 years. 4. Lower limb orthopedic surgeries.

Interventions

Intervention1: fentanyl: Single dose of 2.5 mL volume of 0.5% Hyperbaric Bupivacaine and 25μg Fentanyl 0.5ml given in subarachnoid space on the surgery day. Control Intervention1: dexmedetomidine: Si

Sponsors

Kalinga institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists(ASA) physical status I or II. 2. Either sex (Male/Female). 3. Age between 18-55 years. 4. Lower limb orthopedic surgeries.

Exclusion criteria

Exclusion criteria: 1.ASA III â?? IV patients. 2.Age 55 years. 3.Body mass index >= 30. 4.Height less than 150 cm. 5.Patients using alpha 2 receptor antagonists, calcium channel blocker, ACE inhibitors,ARB 6..Heart block/Dysarhythmia 7.Contraindication to spinal anesthesia (patient refusal, know hypersensitivity to the study drug, coagulation disorder, infection at puncture site, increased intracranial tension and hypotension, spinal deformities.) 8.The use of any opioid or sedative in the week prior to surgery. 9.Pregnancy.

Design outcomes

Primary

MeasureTime frame
1. COMPARE DURATION OF ANESTHESIA BETWEEN TWO GROUPSTimepoint: 1.time to reach T10segment level. 2.time to reach peak sensory level. 3.time to reach peak motor block. 4.time taken for sensory block regression to S2 level. 5.time taken for motor block regression to bromage 0. 6.time to first dose of rescue analgesia.—

Secondary

MeasureTime frame
Sedation score Comparision,Time to urination, and Incidence of side effects, such as nausea, vomiting, shivering, Pruritus, respiratory depression, sedation, bradycardia , Hypotension and urinary retention will be recorded.Timepoint: on the day of surgery—

Countries

India

Contacts

Public ContactKotana satish kumar

Kalinga Institute of Medical Sciences

tapankumarray.ray@gmail.com9861046212

Outcome results

None listed

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