Comparison of two drugs (Dexmedetomidine and Fentanyl) which are used in epidural anaesthesia for lower limb surgery.

Completed

• Registration Number: CTRI/2019/02/017400
• Lead Sponsor: Department of Anaesthesia SSG Hospital Vadodara

Brief Summary

Epidural block is becoming more useful and versatile procedure as it gives opportunity to anaesthesiologists for anaesthesia as well as perioperative analgesia in lower limb orthopaedic surgeries. However epidural anaesthesia is frequently associated with haemodynamic fluctuations due to use of large volumes of local anaesthetic drugs. Hence various adjuvants have been used to prolong duration of intraoperative and post operative analgesia and to minimise the adverse effects of high doses of local anaesthetics.

Dexmedetomidine and fentanyl are very good hypnotic, sedative and analgesic drugs when used as an adjuvant in epidural anaesthesia, both of these drugs have been used safely and effectively without any side effects. So keeping in mind their similar pharmacologic interactions and properties we planned prospective, randomised, clinical study to compare analgesic and sedative effects of both of these drugs when used epidurally as an adjuvant to ropivacaine in epidural anaesthesia in patients undergoing lower limb orthopaedic surgeries.

The aims of study are to evaluate characteristics of sensory blockade, motor blockade, vital parameters, to evaluate level of sedation, duration of effective analgesia, to find out any adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Study Completion: 2016-11-30
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

American Society of Anaesthesiologist (ASA) Grade I and II, Patients scheduled for elective lower limb orthopaedic surgery (Unilateral or bilateral tibia and fibula surgeries like internal fixation , external fixation and plating).

Exclusion Criteria

• 1.Patients’ refusal/unable to give consent.
• 2.Patients with ASA status III and IV.
• 3.Patients with allergy to amide local anaesthetics .
• 4.Patients on α 2 antagonists, ACE inhibitors and calcium channel blockers, B blockers.
• 5.Patients with ischemic heart disease, heart block, Dysrhythmias.
• 6.Pregnant patients and Morbid obesity (BMI>35 kg/square meter).
• 7.Patients with Coagulopathy, Renal and liver impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to onset of anaesthesia at T 10 dermatomal level (min)	7 min

Secondary Outcome Measures

Name	Time	Method
To document duration of effective analgesia, to find out Level of sedation,to find out adverse effects.	1,5,10 upto 24 hrs

Trial Locations

Locations (1)

Medical college and SSG Hospital, Baroda; 🇮🇳 Vadodara, GUJARAT, India

Medical college and SSG Hospital, Baroda

🇮🇳Vadodara, GUJARAT, India

Vijayalaxmi Biradar

Principal investigator

9638716764

biradarvijaya06@gmail.com