Non-invasive, Real-time Anesthetic Drug-monitoring System

NCT ID: NCT02776020

Last Updated: 2016-05-18

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-28

Brief Summary

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The aim of this study is to determine efficacy of the "CorrecDose" device to continuously and non-invasively follow the changes in propofol concentrations in the participants' blood.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Propofol sedated patients

Women undergoing a short trans vaginal ovum retrieval (TVOR) will be sedated with propofol , and monitored non-invasively for changes in blood propofol concentration levels. Propofol dosages will be adapted according to patients vital signs and their reaction to noxious stimuli exerted during the trans vaginal ovum retrieval (TVOR) procedure, irrespective to the proposed study in which these participants undergo.Those changes of administered propofol dosages will be observed by the anesthetic drug monitor (ADM). Propfol is administered by the anesthesiologist in a routine manner and according to anesthesiologist discretion .

CorrecDose Infrared Monitor

Intervention Type DEVICE

The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood

Interventions

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CorrecDose Infrared Monitor

The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women who have signed Informed consent form
* Women undergoing Trans vaginal ovum retrieval (TVOR) for invitro fertilization (IVF) and will be sedated with propofol administered intravenos (IV)

Exclusion Criteria

* Women with background diseases
* Women with chronic use of drug and medication
* Women with peripheral blood vessels problems
* Women with high blood pressure
* Women with body mass index (BMI) score over 35 or less than 18
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ABECASSIS PHILIPPE

Head of women and obstetrics anesthesiology unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Abecassis, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam

Central Contacts

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Philippe Abecassis, MD

Role: CONTACT

+972502061058

Other Identifiers

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0347-15 RBM

Identifier Type: -

Identifier Source: org_study_id

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