Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

Pr Isabelle CONSTANT

Status: Completed

Conditions: Pain

Treatments: Drug: Remifentanil, Ultiva®; Drug: Propofol; Procedure: tetanic stimulations; Procedure: general anesthesia for scheduled gynecological surgery; Device: VideoAlgesiGraph

Study type: Interventional

Funder types: Other

Identifiers

NCT04465773

Pupillo propofol remi stim

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

pupillometry

Experimental group

Description:

General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph

Treatment:

Device: VideoAlgesiGraph

Procedure: tetanic stimulations

Drug: Remifentanil, Ultiva®

Procedure: general anesthesia for scheduled gynecological surgery

Drug: Propofol