NCT04465773

Brief Summary

In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable pain

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

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

January 12, 2016

Last Update Submit

July 7, 2020

Conditions

Pain

Keywords

general anesthesia

Outcome Measures

Primary Outcomes (2)

  • Pupillary diameter

    as measured by VideoAlgesiGraph, in mm

    5 seconds before tetanic stimulation

  • Pupillary diameter

    as measured by VideoAlgesiGraph, in mm

    1 minute after tetanic stimulation

Secondary Outcomes (2)

  • Heart rate

    5 seconds before tetanic stimulation

  • Heart rate

    1 minute after tetanic stimulation

Study Arms (1)

pupillometry

EXPERIMENTAL

General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph

Procedure: general anesthesia for scheduled gynecological surgeryDrug: PropofolDrug: Remifentanil, Ultiva®Procedure: tetanic stimulationsDevice: VideoAlgesiGraph

Interventions

general anesthesia for scheduled gynecological surgeryPROCEDURE
pupillometry
PropofolDRUG

continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55

pupillometry
Remifentanil, Ultiva®DRUG

continuous infusion, target concentration 1 ng/ml

pupillometry
tetanic stimulationsPROCEDURE

10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor

pupillometry
VideoAlgesiGraphDEVICE

non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.

Also known as: VideoAlgesiGraph, Synapsis (TM), Marseille, France
pupillometry

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
  • written informed consent

You may not qualify if:

  • ophthalmic disease
  • neurologic disease
  • preoperative chronic pain or pain medication
  • medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, GeneralPropofolRemifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2016

First Posted

July 10, 2020

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

July 1, 2013

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

FR(1)