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Completed

NCT Number: NCT02998424

Pupillary Diameter Under Different Concentrations of Propofol

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

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Key information

Conditions

Anesthesia

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Continuous infusion

Pupillary diameter measurement

Device

Instantaneous measure

Primary outcomes

  1. Pupillary diameter

    Time frame: Instantaneous measure, 10 minutes after the beginning of the study period

Secondary outcomes

  1. Bispectral Index (BIS)

    Time frame: continuous measure, recorded10 minutes after the beginning of the study period

  2. Heart rate

    Time frame: continuous measure, recorded10 minutes after the beginning of the study period

  3. Observer's Assessment of Alertness/Sedation Scale (OAAS)

    Time frame: 10 minutes after the beginning of the study

    Clinical score

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Registry information

Official study title

Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2016
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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