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Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus

The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02595476
Enrollment
12
Registered
2015-11-03
Start date
2015-01-31
Completion date
2016-03-31
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

analgesia, pupillometry, general anesthesia

Brief summary

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

Interventions

DRUGRemifentanil
DRUGpropofol
DEVICETCI
DEVICEAlgiscan

Pupillometry

Sponsors

Hôpital Armand Trousseau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* ASA 1-2 * scheduled for an idiopathic scoliosis surgical correction

Exclusion criteria

* Ophtalmologic pathology * Neurologic or muscular pathology * Metabolic pathology * Chronic pain

Design outcomes

Primary

MeasureTime frameDescription
Post-stimulation Pupillary reflex dilation30 secondspercentage of dilation compared to pre-stimulation pupillary diameter

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026