Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.
PLEASE NOTE: After conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. Given the technical difficulties we have encountered with the Med-Storm Stress Detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. We will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. We will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation only with skin conductance monitor | Active Comparator | 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. |
|
| Sedation & audiovisual aids with skin conductance monitor | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeiss, Cinema ProMED (audiovisual equipment) | Device |
| ||
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Conductance Response | 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. | Measured in 5 minute intervals, from holding area until PACU discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Beats Per Minute (BPM) | The change in heart rate from holding area until PACU discharge. | Measured from preop to postop |
| Systolic and Diastolic Blood Pressure | The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stavros G. Memtsoudis, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery (HSS) | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Conductance Response | 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. | 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. | Posted | Mean | Standard Deviation | skin conductance responses per second | Measured in 5 minute intervals, from holding area until PACU discharge. |
|
Data will be collected on the day of surgery in the holding area, during the procedure, in the PACU until discharge, and on post-operative day 1, 6 months and 1 year; however no patients experiences any adverse events
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danya DeMeo, Research Assistant | Hospital for Special Surgey | 2127742678 | demeod@hss.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2019 | Dec 6, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Skin Conductance Monitor | Device |
|
| Measured from preop to postop |
| Respiratory Rate | The maxmimum change in postoperative respiratory rate from holding area until PACU discharge. | Measured from preop to postop |
| Number of Patients Who Requested Additional Sedation | Number of patients who requested additional sedative medication in the operating room. | In the operating room |
| Pain Numerical Rating Scale (NRS) Levels | 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. | Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1) |
| Narcotic Consumption | Narcotic consumption "intraop", "postop" and "POD1" | Preop until 24 hours after surgery (holding area until POD 1) |
| State-Trait Anxiety Inventory Questionnaire (STAI) | 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. | holding area and PACU |
| Heidelberg Peri-anaesthetic Questionnaire | 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. | At PACU upon spinal resolution. |
| Client Satisfaction Questionnaire (CSQ-8) | 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) | PACU upon spinal resolution |
| Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids | 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. | Sent to providers at end of surgery. |
| Request of Sedation/Termination of AVA | Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours) | From consent until spinal resolution (avg 6 hs) |
| Number of Participants With Complications | The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...) | Intraoperatively and in the recovery room, average of 3 hours |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | 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 |
| OG001 | 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 |
|
|
| Secondary | Beats Per Minute (BPM) | The change in heart rate from holding area until PACU discharge. | Baseline has the heart rate number but analysis for intraop and postop is the change of the variable. Some patients were discharge earlier | Posted | Mean | Standard Deviation | Beats Per Minute | Measured from preop to postop |
|
|
|
| Secondary | Systolic and Diastolic Blood Pressure | The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge. | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for baseline, intra op and post op was recorded. | Posted | Mean | Standard Deviation | mmHg | Measured from preop to postop |
|
|
|
| Secondary | Respiratory Rate | The maxmimum change in postoperative respiratory rate from holding area until PACU discharge. | Some data was not available for all participants due to equipment not working or due to early discharge | Posted | Mean | Standard Deviation | breaths/minute | Measured from preop to postop |
|
|
|
| Secondary | Number of Patients Who Requested Additional Sedation | Number of patients who requested additional sedative medication in the operating room. | Posted | Count of Participants | Participants | In the operating room |
|
|
|
| Secondary | Pain Numerical Rating Scale (NRS) Levels | 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. | Holding area, PACU arrival, 30 minutes after arrival to PACU and POD1. | Posted | Mean | Standard Deviation | units on a scale | Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1) |
|
|
|
| Secondary | Narcotic Consumption | Narcotic consumption "intraop", "postop" and "POD1" | POD1 - 13 patients from the AVA group were analyzed due to early discharge. | Posted | Mean | Standard Deviation | oral morphine equivalents mg | Preop until 24 hours after surgery (holding area until POD 1) |
|
|
|
| Secondary | State-Trait Anxiety Inventory Questionnaire (STAI) | 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. | 4-point likert scale and consists of 40 questions | Posted | Mean | Standard Deviation | score on a scale | holding area and PACU |
|
|
|
| Secondary | Heidelberg Peri-anaesthetic Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale | At PACU upon spinal resolution. |
|
|
|
| Secondary | Client Satisfaction Questionnaire (CSQ-8) | 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) | This questionnaire was only administered to patients who used the audio-visual aids | Posted | Median | Inter-Quartile Range | scores on a scale | PACU upon spinal resolution |
|
|
|
| Secondary | Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids | 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. | Providers were only asked to provide feedback on the equipment when used by patients in the audiovisual aid group upon surgery end. | Posted | Count of Participants | Participants | Sent to providers at end of surgery. |
|
|
|
| Secondary | Request of Sedation/Termination of AVA | Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours) | 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. | Posted | Count of Participants | Participants | From consent until spinal resolution (avg 6 hs) |
|
|
|
| Secondary | Number of Participants With Complications | The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...) | Posted | Count of Participants | Participants | Intraoperatively and in the recovery room, average of 3 hours |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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 | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| BPM change Intraop |
|
|
| BPM change Postop |
|
|
| DBP change intraop |
|
|
| DBP change postop |
|
|
| SBP Baseline |
|
|
| SBP change intraop |
|
|
| SBP change postop |
|
|
| RR change intraop |
|
|
| RR change postop |
|
|
| PACU arrival |
|
|
| 30 minutes after arrival to PACU |
|
|
| POD1 |
|
|
| OME mg POD1 |
|
| STAI-Trait in holding area |
|
|
| STAI-State in PACU |
|
|
| STAI-Trait in PACU |
|
|