Trial Outcomes & Findings for Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia (NCT NCT02928172)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Approximately 10 minutes

Results posted on

2024-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Depth of Anesthesia Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Depth of Anesthesia Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Overall Study Device did not record data	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depth of Anesthesia n=59 Participants Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Age, Continuous	52.2 years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized White	43 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants
Region of Enrollment United States	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 10 minutes

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.

Outcome measures

Outcome measures
Measure	Depth of Anesthesia n=59 Participants Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Movements as Response to Laryngeal Mask Airway (LMA) Insertion	16 Number of Movements for the whole group

PRIMARY outcome

Timeframe: Intraoperative period (30 minutes to 3 hours)

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.

Outcome measures

Outcome measures
Measure	Depth of Anesthesia n=59 Participants Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Number Coughing/Bucking	21 Number of intraop coughing/bucking

SECONDARY outcome

Timeframe: Intraoperative period (30 minutes to 3 hours)

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

Outcome measures

Outcome measures
Measure	Depth of Anesthesia n=59 Participants Subjects will have the qCON-qNOX and BIS monitor qCON-qNOX: Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor BIS: Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
Number of Intraoperative Movements	21 number of intraop movements

Adverse Events

Depth of Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ofelia Loani Elvir Lazo, Research Project Advisor

Cedars Sinai Medical Center

Phone: 310-423-1682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place