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

  • France
      • 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.
Drug: Propofol
Continuous infusion
Device: Pupillary diameter measurement
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.
Drug: Propofol
Continuous infusion
Device: Pupillary diameter measurement
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.
Drug: Propofol
Continuous infusion
Device: Pupillary diameter measurement
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

Hôpital Armand Trousseau

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.

General Publications

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.

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