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Pupillary Diameter Under Different Concentrations of Propofol

Sponsor
Hôpital Armand Trousseau (Other)
Overall Status
Completed
CT.gov ID
NCT02998424
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pupillary diameter [Instantaneous measure, 10 minutes after the beginning of the study period]

Secondary Outcome Measures

  1. Bispectral Index (BIS) [continuous measure, recorded10 minutes after the beginning of the study period]

  2. Heart rate [continuous measure, recorded10 minutes after the beginning of the study period]

  3. Observer's Assessment of Alertness/Sedation Scale (OAAS) [10 minutes after the beginning of the study]

    Clinical score

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departement d'anesthesie Hopital Armand Trousseau Paris France 75012

Sponsors and Collaborators

  • Hôpital Armand Trousseau

Investigators

  • Study Director: Isabelle Constant, MD-PHD, Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT02998424
Other Study ID Numbers:
  • PD and propofol
First Posted:
Dec 20, 2016
Last Update Posted:
Jun 26, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
propofol
pupillary diameter
Additional relevant MeSH terms:
Propofol

Study Results

No Results Posted as of Jun 26, 2018