Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index

Study Overview
=================
Brief Summary
-----------------
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)

Official Title
-----------------
Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: TRADITIONAL EPIDURAL
* Procedure: DURAL PUNCTURE EPIDURAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-60 ASA I-III grade I unilateral PNL Exclusion Criteria: BMI > 40 kg/m2 drug or alcohol abuse history in the last 6 mounts chronic opoid usage or had chronic pain longer than 6 weeks peripheral and central neurological disorders preoperative hemodynamic disorders irregular sinus rhythm and pace makers diabetes, severe lung and major liver diseases with increasing biluribin use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days who are pregnant and breast feeding not willing to participate allergic or intolerant to any of the drugs in the study procedures that take less than 2 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TRADITIONAL EPIDURAL<br>standard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia | Procedure: TRADITIONAL EPIDURAL<br>* epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)<br>|
| Active Comparator: DURAL PUNCTURE EPIDURAL<br>group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia) | Procedure: DURAL PUNCTURE EPIDURAL<br>* group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of local aneshesics | to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time interval and SPI value dropping | defining time interval between LA administration and SPI value dropping under 50 and hemodynamy | intraoperative | 
| local anesthesic consumption | total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis) | during the procedure/surgery and during 30 minutes of PACU stay |