Comparison of two different routes of administration of Dexmedetomidine for post operative pain relief in patients receiving spinal anesthesia for lower limb orthopedic surgeries.

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046902
• Lead Sponsor: Vydehi Institute of Medical sciences and Research Center

Brief Summary

This study will be conducted in Vydehi Indtuitute of medical sciences and Research Center recruiting patients posted for lower limb orthopedic surgeries. All patients will be receiving spinal anesthesia with Dexmedetomidine either as an adjuvant to spinal as 5 mcg intrathecally Or as an IV supplement at 0.5microgram per kg in 100 ml normal saline 15 minutes before spinal anesthesia.

The effect of this drug on the intervention will be measured in terms of onset and duration of motor and sensory blockade that the spinal anesthesia provides for these surgeries

The study will be conducted on 90 patients over a period of a year.

The results will he directed in the comparison of the two routes of administration of Dexmedetomidine as an adjuvant to spinal anesthesia in lower limb orthopedic surgeries.

The study shall also have secondary objectives of noting shivering sedation and any adverse effects due to the intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1. Patients undergoing lower Limb orthopaedic surgeries under Neuraxial blockade.
• 2. Patients belonging to Americans Society of Anaesthesiologists physical status 1 and 2.

Exclusion Criteria

1. Patients who did not consent 2) Allergies to Dexmedetomidine and Bupivacaine 3) Patients who underwent prolonged surgery requiring epidural activation 4) Emergency surgeries 5) Conversion to general Anesthesia 6) Localised infection at needle site 7) BMI> 35 kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare in both groups onset and duration of motor and sensory blockade	at 0th minute , 3rd, 6th, 9th, 12th, 15th, 30th, 60th minute then at 2nd ,4th, 6th ,10th , 12th and 24th hour

Secondary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	(Tramadol 50mg in 100ml normal saline)
Total rescue analgesic doses given in 24 hours	Time at which rescue Analgesia given is noted.
Sedation scores	Intra operative sedation scores until the surgery is complete is noted.
Incidence of shivering	Intra operative from the time of intervention to completion of surgery.
Adverse effects (if any)	From the time of intervention up to 24 hours post procedure.

Trial Locations

Locations (1)

Vydehi Institute of Medical Sciences and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Vydehi Institute of Medical Sciences and Research Center

🇮🇳Bangalore, KARNATAKA, India

DrAnup Suresh

Principal investigator

9036850860

anupsuresh28@gmail.com