NCT05572164

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 13, 2022

Last Update Submit

October 6, 2022

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • consumption of local aneshesics

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

    intraoperative

Secondary Outcomes (2)

  • time interval and SPI value dropping

    intraoperative

  • local anesthesic consumption

    during the procedure/surgery and during 30 minutes of PACU stay

Study Arms (2)

TRADITIONAL EPIDURAL

ACTIVE COMPARATOR

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

DURAL PUNCTURE EPIDURAL

ACTIVE COMPARATOR

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

Interventions

TRADITIONAL EPIDURALPROCEDURE

epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)

TRADITIONAL EPIDURAL
DURAL PUNCTURE EPIDURALPROCEDURE

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)

DURAL PUNCTURE EPIDURAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-60
  • ASA I-III
  • grade I unilateral PNL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşenur Dostbil

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Ayşenur Dostbil

CONTACT

+905333677796adostbil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

October 7, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 30, 2023

Last Updated

October 7, 2022

Record last verified: 2022-10