Clinical trial NCT06759974: Prevalence of AAGA
Official title: Prevalence of Accidental Awareness Under General Anesthesia in a University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Accidental Awareness During General Anesthesia
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 2546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study will consist of adult patients receiving general anesthesia for elective surgery at Marmara University Pendik Training and Research Hospital and Prof. Dr. Asaf Ataseven Hospital.

Brief summary: Accidental Awareness During General Anesthesia (AAGA) is a condition where patients regain partial or full consciousness during anesthesia, unable to move or react. This can lead to distressing experiences such as pain, fear, or stress, and may cause long-term psychological effects like insomnia, nightmares, and post-traumatic stress disorder. Although AAGA prevalence is reported as 0.1% to 0.2% in Western studies, data specific to populations like Turkey are limited and lack large-scale research. This study aims to investigate the prevalence of AAGA in Turkey and identify associated risk factors, including patient characteristics (e.g., age, gender, comorbidities), surgical variables, and anesthesia techniques. By addressing these factors, the study seeks to enhance anesthesia safety standards and provide critical data for national health policies and practices.

Detailed description: Accidental Awareness During General Anesthesia (AAGA) is defined as a state in which the patient accidentally gains partial or full consciousness during anesthesia and is unable to move or react. This state is often associated with uncomfortable sensations in the patient, such as pain, fear and intense stress during the operation. Awareness is a serious condition that causes anxiety in patients, even if they do not feel any pain. These patients may experience insomnia, recurrent nightmares and post-traumatic stress disorder in the postoperative period. The prevalence and long-term effects of AAGA are of great importance for the safety of anesthesia practices.

In the available literature, the prevalence of AAGA in patients under general anesthesia has been reported as 0.1% to 0.2%. However, since these data are generally based on European and American populations, comprehensive studies in different populations such as Turkey are needed. Studies in Turkey usually have limited sample sizes. This study aims to better understand the prevalence of AAGA in Turkey and to provide important information to contribute to national health policies and anesthesia practice.

In this study, the prevalence of AAGA will be determined and its relationship with patient, surgical and anesthesia factors will be investigated. Determining the risk factors of AAGA is critical for patient safety and is expected to vary in different patient cohorts. In particular, variables such as age, gender, comorbidity, type and duration of anesthesia used are thought to be factors that play a role in the occurrence of AAGA. Moreover, it is suggested that different types and durations of surgery may also affect the risk of AAGA.

This study is expected to contribute to the improvement of safety standards under general anesthesia and to fill the data gap in the national literature by analyzing the prevalence and risk factors of AAGA in Turkey.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing general anesthesia under elective conditions
* American Society of Anesthesiologists (ASA) physical status I-III patients

Exclusion Criteria:

* Patients who are not capable of understanding and analyzing the test
* Patients with neurodegenerative diseases such as dementia, Alzheimer's disease
* Patients not extubated in the postoperative period

Primary outcomes:
measure: Accidental Awareness During General Anesthesia, AAGA
timeFrame: During the 2-24 hours postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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