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Clinical Trials/NCT05572164
NCT05572164
Not yet recruiting
Not Applicable

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

Ataturk University0 sites32 target enrollmentOctober 1, 2022
ConditionsAnalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Ataturk University
Enrollment
32
Primary Endpoint
consumption of local aneshesics
Status
Not yet recruiting
Last Updated
3 years ago

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)

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aysenur Dostbil

Clinical Professor

Ataturk University

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

Outcomes

Primary Outcomes

consumption of local aneshesics

Time Frame: intraoperative

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

Secondary Outcomes

  • time interval and SPI value dropping(intraoperative)
  • local anesthesic consumption(during the procedure/surgery and during 30 minutes of PACU stay)

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