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Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia

NCT02928172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-28

Study results available
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Summary

Hypothesis:

There is a statistically measurable correlation between qNOX and rough clinical signs of insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion, skin Incision, LMA removal. It will reduce the problem of anticipating the nociception in patients undergoing general anesthesia.

Objectives:

1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery under sedation and general anesthesia.
2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and the qCON index of hypnosis.
3. to assess qNOX reliability as a specific indicator of response to nociceptive stimulation.

Conditions

  • Anesthesia
  • Deep Sedation

Interventions

DEVICE

qCON-qNOX

Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor

DEVICE

BIS

Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Roya Yumul, M.D., PhD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2023-02-20
Completion
2023-02-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928172 on ClinicalTrials.gov