Pupillary Diameter Under Different Concentrations of Propofol

NCT ID: NCT02998424

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Continuous infusion

Pupillary diameter measurement

Intervention Type DEVICE

Instantaneous measure

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Continuous infusion

Pupillary diameter measurement

Intervention Type DEVICE

Instantaneous measure

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Continuous infusion

Pupillary diameter measurement

Intervention Type DEVICE

Instantaneous measure

Interventions

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Propofol

Continuous infusion

Intervention Type DRUG

Pupillary diameter measurement

Instantaneous measure

Intervention Type DEVICE

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Armand Trousseau

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Constant, MD-PHD

Role: STUDY_DIRECTOR

Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie

Locations

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Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

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France

References

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Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.

Reference Type DERIVED
PMID: 31490817 (View on PubMed)

Other Identifiers

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PD and propofol

Identifier Type: -

Identifier Source: org_study_id

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