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Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

NCT04000126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-22

No results posted yet for this study

Summary

This study aims to assess the usefulness of pupillometry as a nociceptive indicator during elective orotracheal intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation.

Conditions

Interventions

DEVICE

Pupil reflex dilation measurement (PRD)

Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer

DEVICE

PPI (Pupillary Pain Index)

Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation

DRUG

lidocaine

1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation

DRUG

Placebo

100ml 0,9% NaCl iv 10min before intubation

DEVICE

Bispectral Index (BIS)

Bispectral Index will be monitored to assess the depth of anaesthesia

DEVICE

HR

HR in beats/min will be measured by the electrocardiogram monitor

DEVICE

BP

BP will be measured automatically by an occluding upper arm cuff

Sponsors & Collaborators

  • University of Warmia and Mazury

    lead OTHER

Principal Investigators

  • Ewa Mayzner-Zawadzka, MD,PhD,Prof · Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000126 on ClinicalTrials.gov