Comparing Dexmedetomidine and Fentanyl with Ropivacaine for spinal anaesthesia

Phase 4

Not yet recruiting

• Conditions: Osteopathic, (2) ICD-10 Condition: M848||Other disorders of continuity of bone, (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,

• Registration Number: CTRI/2023/09/058000
• Lead Sponsor: Rajendra institute of medical sciences Ranchi

Brief Summary

Spinal anaesthesia is most widely used technique for lower limb surgeries. Ropivacaine is a long acting amide local anaesthesia. It is less cardiotoxic and has greater motor sensory differentiation. Intrathecal adjuvants prolong the duration and quality of block. Dexmedetomidine is alpha agonist, with high specificity for alpha 2 receptors. It has centrally mediated sedative, analgesic, opioid sparing, sympatholytic properties. It prolongs the sensory and motor block when added to spinal anaesthesia. Fentanyl is potent synthetic opiate agonist. It enhances the analgesic potency of ropivacaine for spinal anaesthesia. This study is undertaken to compare the safety,quality, efficacy of intrathecal demedetomidine 10mcg and 0.75% hyperbaric ropivacaine combination, as compared to fentanyl 25 mcg and 0.75% hyperbaric ropivacaine for orthopaedic lower limb surgeries.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-10
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset and duration of sensory block in all three groups	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 Outcome Measures

Name	Time	Method
time taken for two segment sensory regression	till 12 hrs post induction
total duration of analgesia	till 12hrspost induction
maximum sensory blockade attained & time taken for same	30 -45 mins after induction
onset & duration of motor block	30mins post induction for onset
quality of motor block & time taken for the maximum motor blockade	till 30 mins post induction

Trial Locations

Locations (1)

Rajendra institute of medical sciences,Ranchi; 🇮🇳 Ranchi, JHARKHAND, India

Rajendra institute of medical sciences,Ranchi

🇮🇳Ranchi, JHARKHAND, India

Amritha sai

Principal investigator

9895110764

amrithasai8@gmail.com