Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus

NCT ID: NCT02595476

Last Updated: 2017-04-04

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BIS 55

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)

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

propofol

Intervention Type DRUG

TCI

Intervention Type DEVICE

Tetanic stimulation

Intervention Type PROCEDURE

Algiscan

Intervention Type DEVICE

Pupillometry

BIS 25

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)

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

propofol

Intervention Type DRUG

TCI

Intervention Type DEVICE

Tetanic stimulation

Intervention Type PROCEDURE

Algiscan

Intervention Type DEVICE

Pupillometry

Interventions

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Remifentanil

Intervention Type DRUG

propofol

Intervention Type DRUG

TCI

Intervention Type DEVICE

Tetanic stimulation

Intervention Type PROCEDURE

Algiscan

Pupillometry

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Ophtalmologic pathology
* Neurologic or muscular pathology
* Metabolic pathology
* Chronic pain
Minimum Eligible Age

10 Years

Maximum Eligible Age

20 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 Isabelle COnstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Constant, MD, PHD

Role: STUDY_DIRECTOR

Hopital Armand Trousseau

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, 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.

Reference Type DERIVED
PMID: 28107273 (View on PubMed)

Other Identifiers

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Anesthésie Trousseau 002

Identifier Type: -

Identifier Source: org_study_id

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