Prevalence of AAGA

NCT06759974 | Not Yet Recruiting

• 1 other identifier: 09.2024.1325
• Study Type: observational
• Target: 2,546
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Accidental Awareness During General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  During the 2-24 hours postoperatively.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Central Study Contacts

Ruslan Abdullayev

CONTACT

+905063010833; ruslan_jnr@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12