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NCT02998424 Clinical Trial

Pupillary Diameter Under Different Concentrations of Propofol

Anesthesia Clinical Trial

Official title:
Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02998424
Other study ID # PD and propofol
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 2016

Study information
Verified date June 2018
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 13 Years to 50 Years
Eligibility Inclusion Criteria:

- patient who has reached puberty

- ASA I or II who is scheduled for elective surgery under general anesthesia

Exclusion Criteria:

- neurologic, metabolic, ocular disease

- chronic pain

- under medication that interferes with autonomic nervous system

- obesity

- patient requiering a rapid sequence induction

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Continuous infusion
Device:
• Pupillary diameter measurement
Instantaneous measure

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 Pupillary diameter Instantaneous measure, 10 minutes after the beginning of the study period
Secondary Bispectral Index (BIS) continuous measure, recorded10 minutes after the beginning of the study period
Secondary Heart rate continuous measure, recorded10 minutes after the beginning of the study period
Secondary Observer's Assessment of Alertness/Sedation Scale (OAAS) Clinical score 10 minutes after the beginning of the study
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