Trial Outcomes & Findings for Audiovisual Aid Pilot Study (NCT NCT02506673)
NCT ID: NCT02506673
Last Updated: 2024-12-27
Results Overview
Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.
COMPLETED
NA
26 participants
Measured in 5 minute intervals, from holding area until PACU discharge.
2024-12-27
Participant Flow
Participant milestones
| Measure |
Sedation Only With Skin Conductance Monitor
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Audiovisual Aid Pilot Study
Baseline characteristics by cohort
| Measure |
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
Total
n=26 Participants
Total of all reporting groups
|
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured in 5 minute intervals, from holding area until PACU discharge.Population: We had planned to use the Med-Storm Stress detector to measure skin conductance throughout the procedure until discharge. However, due to repeated technical difficulties with the device and inconclusive data from an analysis of a small number of patients data collection was stopped. No data are presented here.
Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Skin Conductance Response
|
NA skin conductance responses per second
Standard Deviation NA
Due to repeated technical difficulties with the device and inconclusive data from the analysis, the data collection was stopped. There is no data to be presented here.
|
NA skin conductance responses per second
Standard Deviation NA
Due to repeated technical difficulties with the device and inconclusive data from the analysis, the data collection was stopped. There is no data to be presented here.
|
SECONDARY outcome
Timeframe: Measured from preop to postopPopulation: Baseline has the heart rate number but analysis for intraop and postop is the change of the variable. Some patients were discharge earlier
The change in heart rate from holding area until PACU discharge.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Beats Per Minute (BPM)
BPM Baseline
|
71.7 Beats Per Minute
Standard Deviation 10.2
|
66.8 Beats Per Minute
Standard Deviation 8.7
|
|
Beats Per Minute (BPM)
BPM change Intraop
|
17 Beats Per Minute
Standard Deviation 27
|
17 Beats Per Minute
Standard Deviation 11
|
|
Beats Per Minute (BPM)
BPM change Postop
|
2 Beats Per Minute
Standard Deviation 10
|
-6 Beats Per Minute
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Measured from preop to postopPopulation: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for baseline, intra op and post op was recorded.
The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Systolic and Diastolic Blood Pressure
DBP Baseline
|
82.8 mmHg
Standard Deviation 12.7
|
79.6 mmHg
Standard Deviation 9.5
|
|
Systolic and Diastolic Blood Pressure
DBP change intraop
|
3 mmHg
Standard Deviation 8
|
2 mmHg
Standard Deviation 7
|
|
Systolic and Diastolic Blood Pressure
DBP change postop
|
-2 mmHg
Standard Deviation 11
|
-4 mmHg
Standard Deviation 6
|
|
Systolic and Diastolic Blood Pressure
SBP Baseline
|
135.3 mmHg
Standard Deviation 14.5
|
129.2 mmHg
Standard Deviation 15.1
|
|
Systolic and Diastolic Blood Pressure
SBP change intraop
|
7 mmHg
Standard Deviation 10
|
7 mmHg
Standard Deviation 14
|
|
Systolic and Diastolic Blood Pressure
SBP change postop
|
-8 mmHg
Standard Deviation 13
|
-2 mmHg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Measured from preop to postopPopulation: Some data was not available for all participants due to equipment not working or due to early discharge
The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Respiratory Rate
RR Baseline
|
17.2 breaths/minute
Standard Deviation 2.2
|
16.9 breaths/minute
Standard Deviation 1.7
|
|
Respiratory Rate
RR change intraop
|
5 breaths/minute
Standard Deviation 12
|
4 breaths/minute
Standard Deviation 4
|
|
Respiratory Rate
RR change postop
|
-1 breaths/minute
Standard Deviation 3
|
1 breaths/minute
Standard Deviation 5
|
SECONDARY outcome
Timeframe: In the operating roomNumber of patients who requested additional sedative medication in the operating room.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Number of Patients Who Requested Additional Sedation
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)Population: Holding area, PACU arrival, 30 minutes after arrival to PACU and POD1.
Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Pain Numerical Rating Scale (NRS) Levels
Holding area
|
1.9 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 1.4
|
|
Pain Numerical Rating Scale (NRS) Levels
PACU arrival
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
|
Pain Numerical Rating Scale (NRS) Levels
30 minutes after arrival to PACU
|
0.6 units on a scale
Standard Deviation 2.2
|
0 units on a scale
Standard Deviation 0
|
|
Pain Numerical Rating Scale (NRS) Levels
POD1
|
2.5 units on a scale
Standard Deviation 1.7
|
2.1 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Preop until 24 hours after surgery (holding area until POD 1)Population: POD1 - 13 patients from the AVA group were analyzed due to early discharge.
Narcotic consumption "intraop", "postop" and "POD1"
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Narcotic Consumption
OME mg Intraop
|
2.3 oral morphine equivalents mg
Standard Deviation 8.3
|
3.5 oral morphine equivalents mg
Standard Deviation 12.5
|
|
Narcotic Consumption
OME mg Inpatient postop
|
9.8 oral morphine equivalents mg
Standard Deviation 6
|
10.8 oral morphine equivalents mg
Standard Deviation 5
|
|
Narcotic Consumption
OME mg POD1
|
11.0 oral morphine equivalents mg
Standard Deviation 9.9
|
11.5 oral morphine equivalents mg
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: holding area and PACUPopulation: 4-point likert scale and consists of 40 questions
Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
State-Trait Anxiety Inventory Questionnaire (STAI)
STAI-State in holding area
|
33.5 score on a scale
Standard Deviation 11.4
|
32.3 score on a scale
Standard Deviation 7
|
|
State-Trait Anxiety Inventory Questionnaire (STAI)
STAI-Trait in holding area
|
33.4 score on a scale
Standard Deviation 8.9
|
31.8 score on a scale
Standard Deviation 6.0
|
|
State-Trait Anxiety Inventory Questionnaire (STAI)
STAI-State in PACU
|
26.1 score on a scale
Standard Deviation 2.6
|
27.1 score on a scale
Standard Deviation 5.2
|
|
State-Trait Anxiety Inventory Questionnaire (STAI)
STAI-Trait in PACU
|
32.3 score on a scale
Standard Deviation 9.2
|
32.8 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: At PACU upon spinal resolution.The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=12 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Heidelberg Peri-anaesthetic Questionnaire
|
97.2 score on a scale
Standard Deviation 14.0
|
98.9 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: PACU upon spinal resolutionPopulation: This questionnaire was only administered to patients who used the audio-visual aids
The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=12 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ-8)
|
—
|
31.5 scores on a scale
Interval 27.0 to 32.0
|
SECONDARY outcome
Timeframe: Sent to providers at end of surgery.Population: Providers were only asked to provide feedback on the equipment when used by patients in the audiovisual aid group upon surgery end.
Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=11 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids
|
—
|
07 Participants
|
SECONDARY outcome
Timeframe: From consent until spinal resolution (avg 6 hs)Population: This outcome is only providing findings for subjects that has sedation and audiovisual aids with skin conductance monitor. It does not pertain to subjects that had sedation without the AVA.
Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Request of Sedation/Termination of AVA
Number of Participants (AVA Randomization)
|
—
|
13 Participants
|
|
Request of Sedation/Termination of AVA
Request of Sedation/Termination of AVA
|
—
|
13 Participants
|
SECONDARY outcome
Timeframe: Intraoperatively and in the recovery room, average of 3 hoursThe percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)
Outcome measures
| Measure |
Sedation Only With Skin Conductance Monitor
n=13 Participants
Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Midazolam
Skin Conductance Monitor
|
Sedation & Audiovisual Aids With Skin Conductance Monitor
n=13 Participants
Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.
Zeiss, Cinema ProMED (audiovisual equipment)
Midazolam
Skin Conductance Monitor
|
|---|---|---|
|
Number of Participants With Complications
Incidence of Complication Intraop
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complications
Incidence of Complication PACU
|
0 Participants
|
0 Participants
|
Adverse Events
Sedation Only With Skin Conductance Monitor
Sedation & Audiovisual Aids With Skin Conductance Monitor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Danya DeMeo, Research Assistant
Hospital for Special Surgey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place