- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06759974
Prevalence of AAGA
Prevalence of Accidental Awareness Under General Anesthesia in a University Hospital
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ruslan Abdullayev
- Phone Number: +905063010833
- Email: ruslan_jnr@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accidental Awareness During General Anesthesia, AAGA
Time Frame: During the 2-24 hours postoperatively.
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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.
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During the 2-24 hours postoperatively.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09.2024.1325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Accidental Awareness During General Anesthesia
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Brugmann University HospitalRecruitingAccidental Awareness During General AnesthesiaBelgium
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Brugmann University HospitalRecruitingAccidental Awareness During General AnesthesiaBelgium
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The University of QueenslandMedtronicNot yet recruitingAwareness During General AnesthesiaAustralia
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University of MichiganUniversity of Manitoba; Washington University School of Medicine; University... and other collaboratorsCompletedAwareness During General AnesthesiaUnited States
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Sisli Hamidiye Etfal Training and Research HospitalCompletedAnesthesia Awareness | Anesthesia; FunctionalTurkey
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Baskent University Ankara HospitalUnknownTo 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... and other conditionsTurkey
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St George's, University of LondonUnknownAwareness, Anesthesia | Obstetric Anesthesia ProblemsUnited Kingdom
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University Hospital Hradec KraloveRecruitingAnesthesia AwarenessCzechia
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University of PennsylvaniaSuspended
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University of Wisconsin, MadisonRambam Health Care Campus; University of Pennsylvania; RWTH Aachen University; Ludwig-Maximilians... and other collaboratorsCompletedAnesthesia AwarenessUnited States, New Zealand, Israel, Belgium, Germany, Australia, Netherlands