Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: general anesthesia for scheduled gynecological surgery; Drug: Propofol; Drug: Remifentanil, Ultiva®; Procedure: tetanic stimulations; Device: VideoAlgesiGraph

• Registration Number: NCT04465773
• Lead Sponsor: Pr Isabelle CONSTANT

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2013-07
• Study First Submitted: 2016-01-12
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pupillometry	VideoAlgesiGraph	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
pupillometry	general anesthesia for scheduled gynecological surgery	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
pupillometry	tetanic stimulations	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
pupillometry	Remifentanil, Ultiva®	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
pupillometry	Propofol	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

Primary Outcome Measures

Name	Time	Method
Pupillary diameter	1 minute after tetanic stimulation	as measured by VideoAlgesiGraph, in mm

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 minute after tetanic stimulation	as measured by the standard cardioscope

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France