Effects of Different Types of General Anesthesia on Postoperative Pupillary Reactivity
NCT ID: NCT04307238
Last Updated: 2025-07-04
Study Results
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Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2020-03-09
2026-03-10
Brief Summary
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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.
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Detailed Description
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In this study an approach to a more quantitative judgment of postoperative vigilance and consciousness is made by recording pupillometric measurements using a portable infrared pupillometer. The findings of this study may provide new important insights to the meaning of pupillary responses for postoperative vigilance measurement.
Aim: With regard to the lack of knowledge about mechanisms that enable the central nervous system to restore consciousness after the deep functional disorder of the anesthetized state, this study aims to compare general anesthesia techniques (volatile, intravenous) on postoperative changes in pupillary reactivity by using infrared pupillometry.
The primary aim of this study is to investigate changes in pupillary reactivity (pupillary light reflex (PLR, %) in the early postoperative phase (2 hours) after common used types of general anesthesia techniques (inhaled - sevoflurane versus intravenous - propofol).
Secondary aim is to examine whether decreased postoperative PLR predicts a decline in neuropsychological testing (alertness).
Hypotheses: The investigators hypothesis that changes in PLR within the first 2 postoperative hours differs depending on the anesthesia technique used, with a lower decline in PLR after propofol compared to sevoflurane anesthesia.
Furthermore, the investigators hypothesis that postoperative PLR correlates with changes in alertness measured by a neuropsychological test.
Design: This study will be a prospective, randomized double blinded study.
Methods: The study is approved by the local ethics committee and written informed consent will be obtained from each patient. A total of 108 patients aged ≥18 and ≤99 years, with American Society of Anesthesiologist (ASA) physical status scores I-II, scheduled for elective ENT surgery will be enrolled. Baseline assessment of pupillometry and neuropsychological test will be carried out before surgery (baseline) and at predefined time intervals during the first 2 postoperative hours after the end of anesthesia. Results (AUC, PLR%) will be compared between both anesthesia groups.
Primary outcome parameter will be the AUC of PLR (percentage change, %) measured every 15 minutes during the first 2 postoperative hours. Secondary outcome parameter will include the neuropsychological test score (Digit Symbol Substitution Test (DSST), the Visual Intrinsic Alertness Test (VIA) and the Trail making Test (TMT)) will be performed every 30 minutes after general anesthesia (sevoflurane, propofol maintained).), assessed every 30 min up to 2 hours after discontinuation of anesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Propofol group
General anesthesia will be maintained by continually intravenous administered propofol.
PLR
PLR measurements will be performed within the first 2 postoperative hours.
Alertness testing
Preoperative (baseline) and every 30 minutes postoperative computer based alertness testing will be performed.
Propofol anesthesia
Maintenance of anesthesia will be performed using propofol.
Sevoflurane Group
General anesthesia will be maintained by inhalative administered sevoflurane.
PLR
PLR measurements will be performed within the first 2 postoperative hours.
Alertness testing
Preoperative (baseline) and every 30 minutes postoperative computer based alertness testing will be performed.
Sevoflurane anesthesia
Maintenance of anesthesia will be performed using sevoflurane.
Interventions
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PLR
PLR measurements will be performed within the first 2 postoperative hours.
Alertness testing
Preoperative (baseline) and every 30 minutes postoperative computer based alertness testing will be performed.
Propofol anesthesia
Maintenance of anesthesia will be performed using propofol.
Sevoflurane anesthesia
Maintenance of anesthesia will be performed using sevoflurane.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-II
* Patients undergoing elective ENT surgery under general anesthesia
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Marita Windpassinger M.D.
Principal Investigator
Locations
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Medical University Vienna
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1520/2019
Identifier Type: -
Identifier Source: org_study_id
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