Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465773
• Other study ID #: Pupillo propofol remi stim
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2020
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• general anesthesia for scheduled gynecological surgery

Drug:
• Propofol
continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55
• Remifentanil, Ultiva®
continuous infusion, target concentration 1 ng/ml

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

Device:
• VideoAlgesiGraph
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.

Locations

Country	Name	City	State
France	Departement d'anesthesie Hopital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupillary diameter	as measured by VideoAlgesiGraph, in mm	5 seconds before tetanic stimulation
Primary	Pupillary diameter	as measured by VideoAlgesiGraph, in mm	1 minute after tetanic stimulation
Secondary	Heart rate	as measured by the standard cardioscope	5 seconds before tetanic stimulation
Secondary	Heart rate	as measured by the standard cardioscope	1 minute after tetanic stimulation