Pupillary Diameter Under Different Concentrations of Propofol

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

Official Title
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Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol
* Device: Pupillary diameter measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol 1 µg/ml<br>Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. | Drug: Propofol<br>* Continuous infusion<br>Device: Pupillary diameter measurement<br>* Instantaneous measure<br>|
| Experimental: Propofol 2 µg/ml<br>Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. | Drug: Propofol<br>* Continuous infusion<br>Device: Pupillary diameter measurement<br>* Instantaneous measure<br>|
| Experimental: Propofol 3 µg/ml<br>Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. | Drug: Propofol<br>* Continuous infusion<br>Device: Pupillary diameter measurement<br>* Instantaneous measure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary diameter |  | Instantaneous measure, 10 minutes after the beginning of the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral Index (BIS) |  | continuous measure, recorded10 minutes after the beginning of the study period | 
| Heart rate |  | continuous measure, recorded10 minutes after the beginning of the study period | 
| Observer's Assessment of Alertness/Sedation Scale (OAAS) | Clinical score | 10 minutes after the beginning of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, pupillary diameter