NCT02998424

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

December 13, 2016

Last Update Submit

June 25, 2018

Conditions

Anesthesia

Keywords

propofolpupillary diameter

Outcome Measures

Primary Outcomes (1)

  • Pupillary diameter

    Instantaneous measure, 10 minutes after the beginning of the study period

Secondary Outcomes (3)

  • 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)

    10 minutes after the beginning of the study

Study Arms (3)

Propofol 1 µg/ml

EXPERIMENTAL

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: PropofolDevice: Pupillary diameter measurement

Propofol 2 µg/ml

EXPERIMENTAL

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: PropofolDevice: Pupillary diameter measurement

Propofol 3 µg/ml

EXPERIMENTAL

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: PropofolDevice: Pupillary diameter measurement

Interventions

PropofolDRUG

Continuous infusion

Propofol 1 µg/mlPropofol 2 µg/mlPropofol 3 µg/ml
Pupillary diameter measurementDEVICE

Instantaneous measure

Propofol 1 µg/mlPropofol 2 µg/mlPropofol 3 µg/ml

Eligibility Criteria

Age13 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patient who has reached puberty
  • ASA I or II who is scheduled for elective surgery under general anesthesia

You may not qualify if:

  • neurologic, metabolic, ocular disease
  • chronic pain
  • under medication that interferes with autonomic nervous system
  • obesity
  • patient requiering a rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

Related Publications (1)

  • 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.

    PMID: 31490817DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Isabelle Constant, MD-PHD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)