NCT04697732

İntraoperative Awareness Under General Anesthesia

The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: Baskent University Ankara Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. The aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with PTSD in Turkish adults. Adult patients will be evaluated 4 time following emergence (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. Each interview will be conducted using the same structured interview (Brice Interview). Descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. Logistic regression will be used to determine the risk factors associated with awareness and PTSD. We believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.

Conditions

• To 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 Analyze the Frequency of Posttraumatic Stress Disorder in Cases With Awareness and Possible Awareness
• To Investigate the Risk Factors That May be Associated With Posttraumatic Stress Disorder

Interventions

Type	Name	Description
OTHER	General anesthesia	Following emergence from general anesthesia, patients will be evaluated at 4 different timepoints; (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

Timeline

• Start date: 2012-07-17
• Primary completion: 2022-07-17
• Completion: 2022-12-31
• First posted: 2021-01-06
• Last updated: 2021-01-06

Locations

1 site across 1 country: Turkey (Türkiye)