Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
Primary Purpose
Analgesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRADITIONAL EPIDURAL
DURAL PUNCTURE EPIDURAL
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TRADITIONAL EPIDURAL
DURAL PUNCTURE EPIDURAL
Arm Description
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
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)
Outcomes
Primary Outcome Measures
consumption of local aneshesics
to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
Secondary Outcome Measures
time interval and SPI value dropping
defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05572164
Brief Title
Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRADITIONAL EPIDURAL
Arm Type
Active Comparator
Arm Description
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
Arm Title
DURAL PUNCTURE EPIDURAL
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
TRADITIONAL EPIDURAL
Intervention Description
epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)
Intervention Type
Procedure
Intervention Name(s)
DURAL PUNCTURE EPIDURAL
Intervention Description
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 Measure Information:
Title
consumption of local aneshesics
Description
to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
time interval and SPI value dropping
Description
defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
Time Frame
intraoperative
Title
local anesthesic consumption
Description
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)
Time Frame
during the procedure/surgery and during 30 minutes of PACU stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşenur Dostbil
Phone
+905333677796
Email
adostbil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşenur Dostbil
Organizational Affiliation
Ataturk University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
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