Pupillary Diameter Under Different Concentrations of Propofol
June 25, 2018 updated by: Pr Isabelle CONSTANT, Hôpital Armand Trousseau
Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75012
- Departement d'anesthesie Hopital Armand Trousseau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Propofol 1 µg/ml
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. |
Continuous infusion
Instantaneous measure
|
|
EXPERIMENTAL: Propofol 2 µg/ml
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. |
Continuous infusion
Instantaneous measure
|
|
EXPERIMENTAL: Propofol 3 µg/ml
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. |
Continuous infusion
Instantaneous measure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pupillary diameter
Time Frame: Instantaneous measure, 10 minutes after the beginning of the study period
|
Instantaneous measure, 10 minutes after the beginning of the study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bispectral Index (BIS)
Time Frame: continuous measure, recorded10 minutes after the beginning of the study period
|
continuous measure, recorded10 minutes after the beginning of the study period
|
|
|
Heart rate
Time Frame: continuous measure, recorded10 minutes after the beginning of the study period
|
continuous measure, recorded10 minutes after the beginning of the study period
|
|
|
Observer's Assessment of Alertness/Sedation Scale (OAAS)
Time Frame: 10 minutes after the beginning of the study
|
Clinical score
|
10 minutes after the beginning of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (ACTUAL)
October 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
December 16, 2016
First Posted (ESTIMATE)
December 20, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 25, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD and propofol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.