Comparison Of A Drug Dexmedetomidine by Two Different Route Intravenous or Intrathecal With Ropivacaine Heavy in Spinal Block for Lower Limb Orthopaedic Surgery

Phase 4

Not yet recruiting

• Conditions: Fracture of lower end of femur, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia, (5) ICD-10 Condition: S723||Fracture of shaft of femur,

• Registration Number: CTRI/2025/06/089076
• Lead Sponsor: Maharana Bhupal Government Hospital

Brief Summary

The aim of the study will be to evaluate and compare the effect of intravenous versus intrathecal dexmedetomidine as an adjuvant to hyperbaric 0.75% ropivacaine in spinal anaesthesia for lower limb orthopaedic surgery with

Primary objective - to evaluate and compare the duration of analgesia

Secondary objectives- to evaluate and compare onset and duration of sensory and motor block, peak sensory level achieved, time to reach peak sensory level, maximum bromage score achieved, consumption of rescue analgesic drug in 24 hours post operatively, sedation score, haemodynamic parameters, adverse effects,if any.



This study will be conducted in patient who will fulfill the inclusion criteria will be enrolled in the study. They will be randomly into two equal groups of 30 patients in each group.



Group IV - Subarachnoid block with 0.75% of hyperbaric ropivacaine 2.5ml (18.75 mg) + normal saline 0.1ml and IV infusion of 0.5mcg per kg dexmedetomidine in 100ml NS over 15 min

Group IT - Subarachnoid block with 0.75% of hyperbaric ropivacaine 2.5ml (18.75 mg) + 5mcg dexmedetomidine and IV infusion of 100ml NS over 15 min

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-17
• Study Start: 2025-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patient with ASA physical status Grade I and II Patient undergoing elective surgery under spinal anaesthesia Patient with Mallampati Class I and II.

Exclusion Criteria

• Pregnant patients.
• Patients having coagulation abnormalities, platelet count less than 75000, INR more than 1.5, or on anticoagulants.
• Patients having systemic illness (severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic, valvular,congenital heart diseases, psychiatric, hematological disorder).
• Patients having any absolute contraindications for spinal anesthesia.
• Patient refusal to participate in study.
• Any allergy to study drugs or local anaesthetic drugs.
• Patients with BMI more than 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate and Compare the Duration of Analgesia.	0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour

Secondary Outcome Measures

Name	Time	Method
Onset and duration of sensory block	Onset and duration of motor block

Trial Locations

Locations (1)

Maharana Bhupal Government Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

Maharana Bhupal Government Hospital

🇮🇳Udaipur, RAJASTHAN, India

Dr Anuradha Vyas

Principal investigator

9468608278

anuradhavyas03@gmail.com