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

NCT02928172 | Completed Results FDA Device

• 1 other identifier: Pro00043738
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and the qCON index of hypnosis.
3. 3.to assess qNOX reliability as a specific indicator of response to nociceptive stimulation.

Conditions

Anesthesia; Deep Sedation

Keywords

q-CON; q-NOX; BIS; Electroencephalograms (EEG); Laryngeal Mask Airway (LMA); Sedation; General Anesthesia

Outcome Measures

Primary Outcomes (2)

• Movements as Response to Laryngeal Mask Airway (LMA) Insertion

  Correlation between qNOX-qNOX and rough clinical signs of insufficient anti-nociception during Laryngeal Mask Airway (LMA) insertion The Laryngeal Mask Airway (LMA) insertion occurs during the induction, lasting an average of 5-10 minutes. Total number of movements reported for the group as a whole and not per participant.

  Approximately 10 minutes

• Number Coughing/Bucking

  Coughing/bucking as a response to intraoperative stimuli. The total number of coughing/bucking reported intraoperatively for the group as a whole was recorded. The intraoperative period lasted approximately 30 min to 3 hours.

  Intraoperative period (30 minutes to 3 hours)

Secondary Outcomes (1)

• Number of Intraoperative Movements

  Intraoperative period (30 minutes to 3 hours)

Study Arms (1)

Depth of Anesthesia

OTHER

Subjects will have the qCON-qNOX and BIS monitor

Device: qCON-qNOX; Device: BIS

Interventions

qCON-qNOX DEVICE

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

Depth of Anesthesia

BIS DEVICE

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

Depth of Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo general surgical procedures with general anesthesia/LMA.
• Willingness and ability to sign an informed consent document.
• years of age.
• ASA Class I - III adults of either sex

You may not qualify if:

• Inability to consent
• Withdrawal criteria
• Electrodes should be changed when patient's skin impedance value exceeds 15 kΩ after conditioning skin properly. If after two changes of electrodes, impedance remains above 15 kΩ, patient will be excluded from the present study.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Results Point of Contact

• Title: Dr. Ofelia Loani Elvir Lazo, Research Project Advisor
• Organization: Cedars Sinai Medical Center

loani.elvir-lazo@cshs.org

310-423-1682

Study Officials

• Roya Yumul, M.D., PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 10, 2016
• Study Start: January 2, 2018
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: May 28, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)