Non-invasive, Real-time Anesthetic Drug-monitoring System (ADM)

May 15, 2016 updated by: ABECASSIS PHILIPPE, Rambam Health Care Campus
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women undergoing propofol sedation while undergoing trans vaginal ovum retrieval (TVOR) for in vitro fertilization (IVF).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 .
Device: CorrecDose Infrared Monitor
The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Propofol Blood Levels
Time Frame: Half hour
Graphic display on monitor of real-time changes
Half hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Philippe Abecassis, MD, Rambam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 15, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 15, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0347-15 RBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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