NCT03248908

Brief Summary

In this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 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

August 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

3.9 years

First QC Date

August 1, 2017

Last Update Submit

May 12, 2023

Conditions

Pain, AcuteAnesthesia

Keywords

pupillary reflexnociceptionheart rateintraoperative monitoring

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Numeric rating scale (NRS) pain assessment

    From patient extubation until postoperative day 5

  • Postoperative analgesia

    Analgetic consumption

    From patient extubation until postoperative day 5

Secondary Outcomes (10)

  • Stimulation intensity to elicit PDR

    From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours

  • Baseline pupil diameter

    From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours

  • Pupillary dilation reflex amplitude

    From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours

  • Pupillary pain index (PPI)

    From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours

  • Opioid usage during surgery

    From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours

  • +5 more secondary outcomes

Study Arms (4)

Intervention 1

EXPERIMENTAL

Pupillary dilation reflex based perioperative intravenous remifentanil administration. Starting dose 5 ng/ml by continous infusion, dosage adjustments are made after pupillary dilation reflex assessment every 10 minutes. When PPI score is 1, the dosage is decreased with 0.2 ng/ml. When PPI score is greater than 1, the dosage is increased with 0.2 ng/ml.

Diagnostic Test: Pupillary dilation reflex

Intervention 2

ACTIVE COMPARATOR

Anesthesiologist based perioperative intravenous remifentanil administration (daily practice, standard of care). Starting dose 5 ng/ml, dosage adjustments are made when deemed necessary by attending anesthesiologist.

Other: Standard of care

Intervention 3

EXPERIMENTAL

Pupillary dilation reflex based perioperative intravenous sufentanil administration. Starting dose 0.1 mcg/kg bolus, dosage adjustments are made after pupillary dilation reflex assessment every 10 minutes. When PPI score is 1, no supplementary administration is executed. When PPI score is greater than 1, a supplementary bolus of 0.1 mcg/kg is given.

Diagnostic Test: Pupillary dilation reflex

Intervention 4

ACTIVE COMPARATOR

Anesthesiologist based perioperative intravenous sufentanil administration (daily practice, standard of care). Starting dose 0.1 mcg/kg bolus, dosage adjustments are made when deemed necessary by attending anesthesiologist.

Other: Standard of care

Interventions

Pupillary dilation reflexDIAGNOSTIC_TEST

Perioperative pupillary dilation reflex assessment is executed every 10 minutes from start sedation until extubation in patients allocated to study arm Intervention 1 and Intervention 3

Intervention 1Intervention 3
Standard of careOTHER

Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement)

Intervention 2Intervention 4

Eligibility Criteria

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

You may qualify if:

  • \> 18 jaar
  • Elective abdominal or gynaecological operation
  • ASA (American Society of Anesthesiologists classification): I - II - III

You may not qualify if:

  • History of invasive ophthalmological surgery
  • Known bilateral eye disease
  • Known optical of oculomotor nerve deficit
  • Active psychiatrical disease
  • Proven active pheochromocytoma
  • Opioid usage \> 7 days preoperative
  • Ongoing oncological treatment with chemotherapeutic agents
  • Usage of A-1 adrenergic of beta-blocking agents
  • Preoperative usage of benzodiazepines
  • Topical atropine or phenylephrine (eye droplets)
  • Planned perioperative usage of dopamine antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

  • Vlaenderen DV, Hans G, Saldien V, Wildemeersch D. Pupillary reflex dilation and pain index evaluation during general anesthesia using sufentanil: a double-blind randomized controlled trial. Pain Manag. 2022 Nov;12(8):931-941. doi: 10.2217/pmt-2022-0027. Epub 2022 Oct 3.

    PMID: 36189668DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Davina Wildemeersch, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patient, the performer of the pupillary reflex measurement, and the postoperative health care provider are masked for the study arms.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 15, 2017

Study Start

October 12, 2017

Primary Completion

September 6, 2021

Study Completion

January 31, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

BE(1)