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

Not Applicable

Not yet recruiting

• Conditions: Analgesia
• Interventions: Procedure: TRADITIONAL EPIDURAL; Procedure: DURAL PUNCTURE EPIDURAL

• Registration Number: NCT05572164
• Lead Sponsor: Ataturk University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRADITIONAL EPIDURAL	TRADITIONAL EPIDURAL	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
DURAL PUNCTURE EPIDURAL	DURAL PUNCTURE EPIDURAL	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)

Primary Outcome Measures

Name	Time	Method
consumption of local aneshesics	intraoperative	to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia

Secondary Outcome Measures

Name	Time	Method
time interval and SPI value dropping	intraoperative	defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
local anesthesic consumption	during the procedure/surgery and during 30 minutes of PACU stay	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)