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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595476
Other study ID # Anesthésie Trousseau 002
Secondary ID
Status Completed
Phase N/A
First received November 2, 2015
Last updated March 31, 2017
Start date January 2015
Est. completion date March 2016

Study information

Verified date March 2017
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 10 Years to 20 Years
Eligibility Inclusion Criteria:

- ASA 1-2

- scheduled for an idiopathic scoliosis surgical correction

Exclusion Criteria:

- Ophtalmologic pathology

- Neurologic or muscular pathology

- Metabolic pathology

- Chronic pain

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil

propofol

Device:
TCI

Procedure:
Tetanic stimulation

Device:
Algiscan
Pupillometry

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Armand Trousseau

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-stimulation Pupillary reflex dilation percentage of dilation compared to pre-stimulation pupillary diameter 30 seconds
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