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

NCT02776020 | Unknown DMC

• 1 other identifier: 0347-15 RBM
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Changes in Propofol Blood Levels

  Graphic display on monitor of real-time changes

  Half hour

Study Arms (1)

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

Interventions

CorrecDose Infrared Monitor DEVICE

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

Propofol sedated patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Officials

• Philippe Abecassis, MD

  Rambam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Abecassis, MD

CONTACT

+972502061058; p_abecassis@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of women and obstetrics anesthesiology unit

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 18, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share