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

• Sponsor: Ataturk University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05572164
• Collaborator: (none)
• Enrollment: 32
• Arms: 2
• Anticipated Duration (Months): 14.9

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: TRADITIONAL EPIDURAL; Procedure: DURAL PUNCTURE EPIDURAL	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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)
Active Comparator: 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)	Procedure: 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)

Outcome Measures

Primary Outcome Measures

1. consumption of local aneshesics [intraoperative]

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

Secondary Outcome Measures

1. time interval and SPI value dropping [intraoperative]

   defining time interval between LA administration and SPI value dropping under 50 and hemodynamy

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ataturk University

Investigators

• Study Director: Ayşenur Dostbil, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aysenur Dostbil, Clinical Professor, Ataturk University
• ClinicalTrials.gov Identifier: NCT05572164
• Other Study ID Numbers: B.30.2.ATA.0.01.00/576
• First Posted: Oct 7, 2022
• Last Update Posted: Oct 7, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Agnosia

Study Results

No Results Posted as of Oct 7, 2022