Psychological Effect of Explicit Recall After Sedation (PEERS)

Study Overview
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Brief Summary
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Awareness, or explicit recall, under sedation is often intended and expected by anesthesiologists and is assumed that does not associate with any sequelae. Thus, awareness under sedation is a common event and is estimated to occur in around one-quarter of patients in our population. However, two recent registry studies suggested some patients with awareness under sedation have comparable psychological sequelae to those patients with awareness during general anesthesia. As such, we plan to conduct a a single center, prospective cohort study to evaluate the incidence, experience and psychological consequence of awareness under sedation. In this study, we will prospectively include 2500 patients who will be scheduled to have major joint replacement surgery under regional anesthesia and sedation at University Hospital, London Health Sciences Center. All participants will be assessed at four separate time points including: Enrollment/Surgical Preparatory Area (  2 hours before surgery) Post Anesthesia Care Unit (or up to 6 hours after surgery) Postoperative day one (in hospital) Postoperative 3 months (expected to be after discharge via telephone)

Official Title
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Psychological Effect of Explicit Recall After Sedation

Conditions
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Awareness, Anesthesia, Post Traumatic Stress Disorder, Depression

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (>18 years old) Scheduled to have orthopedic surgery or joint replacement therapy under sedation/regional anesthesia Patient is able to communicate in English ASA I-V Exclusion Criteria: Unable to obtain informed consent Patient received General Anesthesia (GA) or conversion to GA during their surgical procedures Unable to conduct the survey such as language barrier, overt psychiatric disorder thought to interfere with the reliability of the interview (e.g. dementia etc) Patient who is expected to require mechanical ventilation at postoperative period (i.e. unable to perform surveys at Post-Anesthesia Care Unit (PACU) and postoperative day one) Unable to follow up via phone or attend a postoperative follow-up visit at postoperative 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explicit recall | Explicit recall will be assessed by Modified Brice Questionnaire | Up to 6 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explicit Recall | Explicit recall will be assessed by Modified Brice Questionnaire The Michigan Awareness Classiﬁcation is used to report the levels of sensation during awareness. 5 Levels of sensation are classiﬁed as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience. | Postoperative Day 1 | 
| Sensation During Awareness | The Michigan Awareness Classification - Michigan Score The Michigan Awareness Classiﬁcation is used to report the levels of sensation during awareness. 5 Levels of sensation are classiﬁed as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience. | Postoperative Day 1 | 
| Details of recall experience | Light, smell, and other feelings The Michigan Awareness Classiﬁcation is used to report the levels of sensation during awareness. 5 Levels of sensation are classiﬁed as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience. | Postoperative Day 1 | 
| Post Traumatic Stress Disorder | PCL-S Questionnaire | Postoperative 3 Months | 
| Depression | PHQ-9 Questionnaire | Postoperative 3 Months |