Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-06 @ 7:02 AM
Study NCT ID:
NCT02843893
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.
Status:
COMPLETED
Status Verified Date:
2016-07
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:
PUPILLO REA
Brief Summary:
Sedation-analgesia is an important therapy for patients in resuscitation. It requires a surveillance, in order to avoid excessive or insufficient dosages of sedative or nonmorphinics, sources of side effects. Yet, means of surveillance are limited in resuscitation care : variations of blood pressure and heart rate are not very sensitive criterias. Clinical scales to measure the sedation and analgesia level were proposed for patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold by pupillometry for patients in resuscitation receiving a sedation-analgesia.
The main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.
The main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.
Detailed Description:
Secondary goals will be to bring this measures back to the pain score BPS and the pupillary diameter measured during a painful care (tracheal aspiration), as well as morphinics dosage.
Study Oversight
Has Oversight DMC:
False
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?: