Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04465773

Enrollment

Registered

2020-07-10

Start date

2012-01-31

Completion date

2013-07-31

Last updated

2020-07-10

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

Conditions

Pain

Keywords

general anesthesia

Brief summary

In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

Detailed description

The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion. Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55. Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded. Then, propofol and remifentanil infusions were discontinued, and patients were extubated.

Interventions

PROCEDUREgeneral anesthesia for scheduled gynecological surgery

DRUGPropofol

continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55

DRUGRemifentanil, Ultiva®

continuous infusion, target concentration 1 ng/ml

PROCEDUREtetanic stimulations

10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor

DEVICEVideoAlgesiGraph

non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation * written informed consent

Exclusion criteria

* ophthalmic disease * neurologic disease * preoperative chronic pain or pain medication * medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)

Design outcomes

Primary

Measure	Time frame	Description
Pupillary diameter	5 seconds before tetanic stimulation	as measured by VideoAlgesiGraph, in mm

Secondary

Measure	Time frame	Description
Heart rate	5 seconds before tetanic stimulation	as measured by the standard cardioscope

Countries

France

Outcome results

None listed

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