Viewing Study NCT04465773



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Study NCT ID: NCT04465773
Status: COMPLETED
Last Update Posted: 2020-07-10
First Post: 2016-01-12

Brief Title: Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI
Sponsor: Pr Isabelle CONSTANT
Organization: Hôpital Armand Trousseau

Study Overview

Official Title: Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI
Status: COMPLETED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ngml 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None