Prevalence of AAGA

January 3, 2025 updated by: Ruslan Abdullayev, Marmara University

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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

2546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 2-24 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

December 29, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

December 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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