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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05572164
• Other study ID #: B.30.2.ATA.0.01.00/576
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Ataturk University
• Contact: Aysenur Dostbil
• Phone: +905333677796
• Email: adostbil[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 30, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, a2-adrenergic agonists, ß1-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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• TRADITIONAL EPIDURAL
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
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of local aneshesics	to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia	intraoperative
Secondary	time interval and SPI value dropping	defining time interval between LA administration and SPI value dropping under 50 and hemodynamy	intraoperative
Secondary	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