NCT04307238

Brief Summary

Objective: To compare the effects of volatile and intravenous anesthetics on pupillary function after general anesthesia using a portable infrared pupillometer. Design: A monocentric, prospective, double blinded randomized study. Patients: Patients who require elective Ear, Nose and Throat (ENT) surgery under general anesthesia. Interventions: Patients undergoing elective ENT surgery will be assigned to intravenous versus inhalative anesthesia and pupillometric parameters monitored postoperative, using an infrared pupillometer. Outcomes measures: Reported pupillometric parameters after intravenous and inhalative anesthesia. The purpose of this study is to compare general anesthesia techniques (volatile, intravenous) on postoperative changes in pupillary reactivity by using infrared pupillometry.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

6 years

First QC Date

November 22, 2019

Last Update Submit

July 1, 2025

Conditions

Pupillary Reflex Impaired

Keywords

Pupillary Light ReflexGeneral AnesthesiaPostoperative VigilanceAlertnessPostoperative RecoveryInfrared Pupillometry

Outcome Measures

Primary Outcomes (1)

  • The AUC of Pupillary Light Reflex

    The AUC of PLR (percentage change, %) measured every 15 minutes during the first 2 postoperative hours.

    baseline and within the first 2 postoperative hours

Secondary Outcomes (3)

  • Alertness assessed with the Visual Intrinsic Alertness Test Score

    baseline and within the first 2 postoperative hours

  • Alertness assessed with the Trail making Test Score

    baseline and within the first 2 postoperative hours

  • Alertness assessed with the Digit Symbol Substitution Test

    baseline and within the first 2 postoperative hours

Study Arms (2)

Propofol group

OTHER

General anesthesia will be maintained by continually intravenous administered propofol.

Diagnostic Test: PLRDiagnostic Test: Alertness testingProcedure: Propofol anesthesia

Sevoflurane Group

OTHER

General anesthesia will be maintained by inhalative administered sevoflurane.

Diagnostic Test: PLRDiagnostic Test: Alertness testingProcedure: Sevoflurane anesthesia

Interventions

PLRDIAGNOSTIC_TEST

PLR measurements will be performed within the first 2 postoperative hours.

Also known as: Pupillary light reflex
Propofol groupSevoflurane Group
Alertness testingDIAGNOSTIC_TEST

Preoperative (baseline) and every 30 minutes postoperative computer based alertness testing will be performed.

Also known as: DSST, VIA, TMT
Propofol groupSevoflurane Group
Propofol anesthesiaPROCEDURE

Maintenance of anesthesia will be performed using propofol.

Propofol group
Sevoflurane anesthesiaPROCEDURE

Maintenance of anesthesia will be performed using sevoflurane.

Sevoflurane Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 18 and ≤99 years
  • ASA I-II
  • Patients undergoing elective ENT surgery under general anesthesia

You may not qualify if:

  • Patients aged \< 18 and \>99 years
  • consumption of antidepressants, tranquilizer, psychotropic medications
  • history of mental illness, neurosurgery, neurological or psychiatric disease
  • ophthalmologic disease
  • preexisting cognitive impairment
  • Patients with drug dependence, alcoholism
  • the patients' inability to follow procedures
  • implanted electronic medical devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Marita Windpassinger, MD

CONTACT

+43 1 40400 41020marita.windpassinger@meduniwien.ac.at

Olga Plattner, Prof.MD

CONTACT

+43 1 40400 41020olga.plattner@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded study design (participants, evaluator)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2019

First Posted

March 13, 2020

Study Start

March 9, 2020

Primary Completion

March 10, 2026

Study Completion

March 10, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Locations

AU(1)