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Patients will be randomly assigned to either one of two groups:
Monitoring and anesthesia regimen will be standardized
Before consent patients will be thoroughly informed about possible risks or benefits and about their possibilities to end the study at any time point or to ask for additional sedation if they feel uncomfortable or anxious. After they consent, they will be randomly assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2). Each group will consist of 30 patients. The randomization schedule will be created by a member of the Healthcare Research Institute using SAS software, who is not otherwise involved in the trial.
The intraoperative anesthesia regimen will be standardized:
All patients will be monitored according to the American Society of Anesthesiologists standard, receive either a radial arterial line or non-invasive blood pressure measurement according to the preferences of the anesthesia provider and O2 via nasal cannula or face mask in the operation room and the recovery room.
ondansetron,decadron and ketorolac may be administered as per clinical judgment of the attending anesthesiologist.
Patients in both groups will receive neuraxial anesthesia. The attending anesthesiologist is free to add an ultrasound guided peripheral nerve block:
Opioids and other medications with sedative or respiratory depressant side effects that are not specifically mentioned above should be omitted (if possible without harm for the patient) Patients in the audiovisual distraction group will choose a movie, start watching it in the holding area and continue watching it in the operation room as well as the first 30 min in the recovery room. Audiovisual equipment will be removed for transfers or at patient request.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiovisual Distraction | Experimental | Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. |
|
| Standard of care sedation | No Intervention | Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiovisual Distraction | Device | watching a movie using video glasses and headphones |
|
| Measure | Description | Time Frame |
|---|---|---|
| Desaturations | number of desaturation events (SpO2< 90% for ≥ 10 sec) measured during this time frame | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Interventions | each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs. | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros G Memtsoudis, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Audiovisual Distraction | Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. Audiovisual Distraction: watching a movie using video glasses and headphones |
| FG001 | Standard of Care Sedation | Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Audiovisual Distraction | Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. Audiovisual Distraction: watching a movie using video glasses and headphones |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Desaturations | number of desaturation events (SpO2< 90% for ≥ 10 sec) measured during this time frame | Posted | Median | Inter-Quartile Range | number of desaturation events | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) |
|
All-cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed
All-cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Audiovisual Distraction | Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider. Audiovisual Distraction: watching a movie using video glasses and headphones |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marla Sharp, MPH, MA | Hospital for Special Surgery | 646-797-8419 | sharpm@hss.edu |
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| 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 | Jun 12, 2020 | Jun 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Additional Sedation | Patient request for additional sedation | intraoperative |
| Patient Satisfaction | Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions). | 10 minutes before recovery room discharge |
| Alertness Levels | Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points. | 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge |
| BG001 | Standard of Care Sedation | Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. |
|
|
| Secondary | Airway Interventions | each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs. | Posted | Number | airway interventions | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) |
|
|
|
| Secondary | Additional Sedation | Patient request for additional sedation | Posted | Count of Participants | Participants | intraoperative |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions). | Posted | Mean | Inter-Quartile Range | score on a scale | 10 minutes before recovery room discharge |
|
|
|
| Secondary | Alertness Levels | Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points. | Posted | Median | Inter-Quartile Range | score on a scale | 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care Sedation | Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |