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A STUDY TO COMPARE EFFECTS OF ADDITIVES IN SPINAL ANAESTHESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES : BUPIVACAINE WITH DEXMEDITOMIDINE VS BUPIVACAINE WITH FENTANYL.

A COMPARATIVE STUDY OF EFFICACY OF INTRATHECAL 0.5% BUPIVACAINE WITH DEXMEDETOMIDINE VS 0.5% BUPIVACAINE WITH FENTANYL IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES : A RANDOMISED DOUBLE BLIND CONTROLLED TRIAL .

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033600
Enrollment
104
Registered
2021-05-13
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: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 0.5% BUPIVACAINE WITH DEXMEDETOMINE: 3ml of 0.5% hyperbaric Bupivacaine with 0.5ml of 5mcg Dexmedetomidine ,A total of 3.5ml Control Intervention1: 0.5% BUPIVACAINE WITH FENTANYL: 3ml o

Sponsors

MGIMS Sevagram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists Grade I and II patients. Age 20-60 years of either gender. Patients undergoing lower limb Surgeries . Patients free from cardiac and respiratory dysfunction. Height is more than 4 feet.

Exclusion criteria

Exclusion criteria: American Society of Anesthesiologists Grade III and IV patients. Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection. Patients with haemodynamic instability. Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases,etc. Patient with allergy to or history of hypersensitivity to local anaesthetics. Emergency surgeries. Patient with known allergy to opioids. Patients with a history of severe PDPH or PONV after spinal anaesthesia. Patientâ??s refusal. Orthopaedic Surgeries requiring level of block above T8. Lower limb orthopaedic surgeries around Hip joint. Joint replacement surgeries. Orthopaedic surgeries requiring prolonged duration of action that will require supplementation with epidural catheterization or general anaesthesia.

Design outcomes

Primary

MeasureTime frame
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmeditomidine & 0.5% Bupivacaine with Fentanyl in terms of the duration of sensory and motor blockade. Timepoint: Till 120 minutes—

Secondary

MeasureTime frame
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmedetomidine & 0.5% Bupivacaine with Fentanyl in terms of The onset of sensory and motor blocks achieved. The level of blockade achieved . The efficacy of postoperative analgesia . Side effects like hemodynamic changes ( hypotension and bradycardia) ,sedation, pruritus, post-operative nausea and vomiting and respiratory depression. Timepoint: till 120 minutes—

Countries

India

Contacts

Public ContactJIDNYASA MOON

Mahatma Gandhi Institute Of Medical Science, Sevagram.

suchetatidke@mgims.ac.in9850510019

Outcome results

None listed

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