N/A
Completed N=60
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia
Anesthesia · Deep Sedation
Source: ClinicalTrials.gov NCT02928172 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Movements as Response to Laryngeal Mask Airway (LMA) Insertion — 16 Number of Movements for the whole group
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movements as Response to Laryngeal Mask Airway (LMA) Insertion |
16 | — |
| PRIMARY Number Coughing/Bucking |
21 | — |
| SECONDARY Number of Intraoperative Movements |
21 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02928172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.