Accidental Awareness During General AnesthesiaNCT06759974
Prevalence of AAGA
An observational study of Accidental Awareness During General Anesthesia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Accidental Awareness During General Anesthesia
- How many people
- 459 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2024to 1 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing general anesthesia under elective conditions
- American Society of Anesthesiologists (ASA) physical status I-III patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Istanbul, 34912
About this study
Official title: Prevalence of Accidental Awareness Under General Anesthesia in a University Hospital
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative patients | The population will consist of patients receiving general anesthesia for elective surgery. Written informed consent will be obtained. A questionnaire will be administered to patients undergoing general anesthesia for elective surgery during the 2-24 hours in the postoperative period. Participants will report their experience with AAGA in the perioperative period through the Modified Brice questionnaire. The questionnaire is designed to determine the waking experiences under anesthesia and aims to comprehensively assess the feelings and thoughts that patients feel during this process. In addition, demographic information (age, gender, body mass index, etc.), clinical data (medical history, current health status, etc.), surgical and anesthesia-related information (type of surgery, anesthesia technique used, etc.) will be collected for each patient. These data will be used to identify differences between patients who develop AAGA and those who do not. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accidental Awareness During General Anesthesia, AAGA
Experience of the Accidental Awareness During General Anesthesia in the early perioperative period that will be obtained via a questionnaire during the postoperative day zero.
Measured: During the 2-24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start8 Dec 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Awareness During General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 459 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759974
- Sponsor's protocol ID
- 09.2024.1325
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Accidental Awareness Under General Anesthesia in a University Hospital
- ClinicalTrials.gov ID
- NCT06759974
- Acronym / sponsor ID
- 09.2024.1325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative patients | – | –The population will consist of patients receiving general anesthesia for elective surgery. Written informed consent will be obtained. A questionnaire will be administered to patients undergoing general anesthesia for elective surgery during the 2-24 hours in the postoperative period. Participants will report their experience with AAGA in the perioperative period through the Modified Brice questionnaire. The questionnaire is designed to determine the waking experiences under anesthesia and aims to comprehensively assess the feelings and thoughts that patients feel during this process. In addition, demographic information (age, gender, body mass index, etc.), clinical data (medical history, current health status, etc.), surgical and anesthesia-related information (type of surgery, anesthesia technique used, etc.) will be collected for each patient. These data will be used to identify differences between patients who develop AAGA and those who do not. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing general anesthesia under elective conditions
- American Society of Anesthesiologists (ASA) physical status I-III patients
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accidental Awareness During General Anesthesia, AAGA
Time frame: During the 2-24 hours postoperatively.
Experience of the Accidental Awareness During General Anesthesia in the early perioperative period that will be obtained via a questionnaire during the postoperative day zero.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Awareness During General Anesthesia, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accidental Awareness During General Anesthesia, AAGA (time frame: During the 2-24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.