To Analyze the Frequency of Posttraumatic Stress Disorder in Cases With Awareness and Possible Awareness Clinical Trial
Official title:
The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study
| NCT number | NCT04697732 |
| Other study ID # | KA12/154 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 17, 2012 |
| Est. completion date | December 31, 2022 |
Intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. The aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with PTSD in Turkish adults. Adult patients will be evaluated 4 time following emergence (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. Each interview will be conducted using the same structured interview (Brice Interview). Descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. Logistic regression will be used to determine the risk factors associated with awareness and PTSD. We believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.
| Status | Recruiting |
| Enrollment | 30000 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | July 17, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively, Exclusion Criteria: - ASA V patients - Patients below 18 years of age, - Patient who can not give informed consent, - Patients who have known psychological or psychiatric problems, - Patients who are not suitable for postoperative follow-up |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Baskent University | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Baskent University Ankara Hospital |
Turkey,
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* Note: There are 27 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Modified Brice interview | This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. | One hour after emergence | |
| Primary | Modified Brice interview | This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. | Twenty four hour after emergence | |
| Primary | Modified Brice interview | This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. | One week after emergence | |
| Primary | Modified Brice interview | This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. | One month after emergence. |