Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
Patients will be randomly assigned to either one of two groups: 1. Standard of care sedation 2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library Monitoring and anesthesia regimen will be standardized
Detailed description
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. 1. Standard of care sedation with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect. 2. 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. 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: * Neuraxial anesthesia (combined spinal-epidural, epidural or spinal) as preferred by the attending anesthesiologist. Decadron may be used as in addition to the local anesthetic if the anesthesia provider wishes to do so. * If a peripheral nerve block is performed the appropriate amount of bupivacaine will be administered under ultrasound-guidance as a single shot. * In case an epidural catheter was placed patients will receive a patient controlled epidural analgesia immediately after arrival at the recovery room for postoperative pain management. * 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.
Interventions
watching a movie using video glasses and headphones
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with known OSA (preexisting diagnosis of obstructive sleep apnea (OSA) or patients with a STOP BANG Score of 5 or above) undergoing primary total knee arthroplasty under neuraxial anesthesia
Exclusion criteria
* Contraindications to neuraxial anesthesia or allergy to study medication * Patients with audiovisual impairments prohibiting them from proper use of the study device: * Patients who are blind * Patients with hearing aids * Age \<18 years * Patients with inability to communicate in English or understand the study requirements * Patients with prior history of claustrophobia * Patients with prior history of epilepsy or seizure disorder * Patients undergoing a revision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desaturations | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) | number of desaturation events (SpO2\< 90% for ≥ 10 sec) measured during this time frame |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway Interventions | start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours) | 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. |
| Additional Sedation | intraoperative | Patient request for additional sedation |
| Patient Satisfaction | 10 minutes before recovery room discharge | 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). |
| Alertness Levels | 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgery Cancelled | 1 | 0 |
Baseline characteristics
| Characteristic | Audiovisual Distraction | Total | Standard of Care Sedation |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 8.04 | 66 years STANDARD_DEVIATION 6.99 | 69 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 16 Participants | 9 Participants |
| Region of Enrollment United States | 10 participants | 19 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Desaturations
number of desaturation events (SpO2\< 90% for ≥ 10 sec) measured during this time frame
Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Audiovisual Distraction | Desaturations | 0 number of desaturation events |
| Standard of Care Sedation | Desaturations | 1 number of desaturation events |
Additional Sedation
Patient request for additional sedation
Time frame: intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Audiovisual Distraction | Additional Sedation | 2 Participants |
| Standard of Care Sedation | Additional Sedation | 1 Participants |
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.
Time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Audiovisual Distraction | Airway Interventions | 2 airway interventions |
| Standard of Care Sedation | Airway Interventions | 7 airway interventions |
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.
Time frame: 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Audiovisual Distraction | Alertness Levels | 0 score on a scale |
| Standard of Care Sedation | Alertness Levels | 0 score on a scale |
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).
Time frame: 10 minutes before recovery room discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Audiovisual Distraction | Patient Satisfaction | 55 score on a scale |
| Standard of Care Sedation | Patient Satisfaction | 54 score on a scale |