Clinical trial NCT04697732: İntraoperative Awareness Under General Anesthesia
Official title: The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Investigate the Incidence and Causes of Awareness During General Anesthesia
To Investigate the of Dreaming During Anesthesia
To Investigate the Intra-operative Experiences of Patients Who Report Awareness
To Investigate the Risk Factors That May be Associated With Awareness
To Analyze the Frequency of Posttraumatic Stress Disorder in Cases With Awareness and Possible Awareness
To Investigate the Risk Factors That May be Associated With Posttraumatic Stress Disorder
Keywords: intraoperative awareness
general anesthesia
dreaming
incidence
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Modified Brice interview
timeFrame: One hour after emergence
measure: Modified Brice interview
timeFrame: Twenty four hour after emergence
measure: Modified Brice interview
timeFrame: One week after emergence
measure: Modified Brice interview
timeFrame: One month after emergence.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University
name: Bahattin Tuncali
role: PRINCIPAL_INVESTIGATOR
References:
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