NCT03140241

Brief Summary

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 2, 2017

Last Update Submit

May 16, 2018

Conditions

Nociceptive PainMonitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

  • Stimulation Intensity

    Necessary stimulation intensity to dilate the pupil more than 13%

    During perioperative period

Secondary Outcomes (3)

  • Pupillary Pain Index score

    During perioperative period

  • Systolic blood pressure

    During PDR measurements

  • Heart rate

    During PDR measurements

Study Arms (1)

PDR measurement

EXPERIMENTAL

Two measurements of PDR perioperatively before and after opioid administration

Procedure: PDR measurement

Interventions

PDR measurementPROCEDURE

PDR measurement at two standardized times perioperatively: 1. : anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50 2. : administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth

Also known as: PPI assessment
PDR measurement

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled abdominal or gynecological surgery
  • ASA I-II

You may not qualify if:

  • History of eye deformity, invasive ophthalmologic surgery
  • Known cranial nerve(s) deficit
  • Infection of the eye
  • Predicted difficult airway management (DAF Guidelines)
  • Chronic opioid use (\>3 months)
  • Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
  • Preoperatively administrated benzodiazepins or antiemetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Links

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michiel Baeten, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Natasja Peeters, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Vera Saldien, MD

    University Hospital, Antwerp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

May 7, 2017

Primary Completion

June 29, 2017

Study Completion

July 20, 2017

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)