Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia (NCT02928172) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia
United States60 participantsStarted 2018-01-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled to undergo general surgical procedures with general anesthesia/LMA.
* Willingness and ability to sign an informed consent document.
* 18 - 80 years of age.
* ASA Class I - III adults of either sex
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Movements as Response to Laryngeal Mask Airway (LMA) Insertion
Timeframe: Approximately 10 minutes
2
Number Coughing/Bucking
Timeframe: Intraoperative period (30 minutes to 3 hours)