NCT02595476

Brief Summary

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2015

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, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

November 2, 2015

Last Update Submit

March 31, 2017

Conditions

Pain

Keywords

analgesiapupillometrygeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Post-stimulation Pupillary reflex dilation

    percentage of dilation compared to pre-stimulation pupillary diameter

    30 seconds

Study Arms (2)

BIS 55

EXPERIMENTAL

1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)

Drug: RemifentanilDrug: propofolDevice: TCIProcedure: Tetanic stimulationDevice: Algiscan

BIS 25

ACTIVE COMPARATOR

1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)

Drug: RemifentanilDrug: propofolDevice: TCIProcedure: Tetanic stimulationDevice: Algiscan

Interventions

RemifentanilDRUG
BIS 25BIS 55
propofolDRUG
BIS 25BIS 55
TCIDEVICE
BIS 25BIS 55
Tetanic stimulationPROCEDURE
BIS 25BIS 55
AlgiscanDEVICE

Pupillometry

BIS 25BIS 55

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA 1-2
  • scheduled for an idiopathic scoliosis surgical correction

You may not qualify if:

  • Ophtalmologic pathology
  • Neurologic or muscular pathology
  • Metabolic pathology
  • Chronic pain

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, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.

    PMID: 28107273DERIVED

MeSH Terms

Conditions

PainAgnosia

Interventions

RemifentanilPropofol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Isabelle Constant, MD, PHD

    Hopital Armand Trousseau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Isabelle COnstant

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 3, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

FR(1)