NCT02942316

Brief Summary

In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable pain

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

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

October 20, 2016

Last Update Submit

May 16, 2018

Conditions

Pain

Keywords

Heart RateReflex, PupillaryMonitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

  • Pupillary Reflex Dilation

    Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia

    Perioperative phase

Secondary Outcomes (2)

  • Patient Movement

    Perioperative phase

  • Vital signs

    Perioperative phase

Study Arms (1)

Pupil dilation reflex measurement

EXPERIMENTAL

Four measurements of PDR during surgery at standardized times

Device: Pupil dilation reflex measurement

Interventions

Pupil dilation reflex measurementDEVICE

Pupillometry (PDR) at four standardized times perioperatively * after induction, before opioid administration * after opioid administration, steady state * surgical incision * end of procedure

Pupil dilation reflex measurement

Eligibility Criteria

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

You may qualify if:

  • Scheduled abdominal surgery
  • ASA I-II

You may not qualify if:

  • History of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance
  • Kown 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

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

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Slappendel, MD, PhD

    University Hospital, Antwerp

    STUDY DIRECTOR

  • Michiel Baeten, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Davina Wildemeersch, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

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

October 20, 2016

First Posted

October 24, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)