Skip to content

Comparative Study of Two Doses of Intrathecal Clonidine as an Adjuvant to Hyperbaric Levobupivacaine for Enhanced Spinal Anesthesia in Femur Fracture Surgeries

An Observational Study Of Comparison Of Two Different Doses Of Intrathecal Clonidine As Adjuvant With Hyperbaric levobupivacaine for subarachnoid blockage characteristics In Femur Fracture Surgeries - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075804
Enrollment
62
Registered
2024-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hyperbaric Levobupivacaine and Clonidine: 0.5% Hyperbaric Levobupivacaine 3ml with Clonidine 30 µg as single injection , intrathecal administration with total duration 6 hours Control I

Sponsors

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to sign informed consent. 2. ASA I & ASA II patients undergoing spinal anaesthesia posted for Femur Fracture Surgeries. 3. Age between 18- 65 years. 4.No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type.

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Allergy to any drugs including test drug. 3. History of seizure disorder. 4. Patient taking clonidine or any other antihypertensives. 5. Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction. 6. ASA III, IV, Patients. 7. Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities)

Design outcomes

Primary

MeasureTime frame
to study the sensory and motor blockage characteristics in spinal anaesthesiaTimepoint: motor and sensory blockage characteristics assessed at 0,2,4,6,8,10 minutes then every 5 minutes upto 30 minutes and then every 15 minutes till the end of surgery.

Secondary

MeasureTime frame
To Assess Sedation Score, Duration of Absolute Analgesia and Effective Analgesia, Number of Rescue Analgesia required in 24 hrs and Complications if any. Timepoint: Four Point Sedation Score will be assessed every 5 minutes for 15 minutes then every 15 minutes till the end of surgery.

Countries

India

Contacts

Public ContactJatin Patel

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre

dr_jatinpatel@yahoo.co.in9879368363

Outcome results

None listed

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