İntraoperative Awareness Under General Anesthesia

• Conditions: To Investigate the of Dreaming During Anesthesia; 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; To Investigate the Incidence and Causes of Awareness During General Anesthesia; To Investigate the Intra-operative Experiences of Patients Who Report Awareness; To Investigate the Risk Factors That May be Associated With Awareness
• Interventions: Other: General anesthesia

• Registration Number: NCT04697732
• Lead Sponsor: Baskent University Ankara Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-17
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06
• Primary Completion: 2022-07-17
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,

Exclusion Criteria

• ASA V patients
• Patients below 18 years of age,
• Patient who can not give informed consent,
• Patients who have known psychological or psychiatric problems,
• Patients who are not suitable for postoperative follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients age above 18 years	General anesthesia	ASA I-IV adult patients over 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively, who can give informed consent, have no known psychological or psychiatric problems, and who are suitable for postoperative follow-up.

Primary Outcome Measures

Name	Time	Method
Modified Brice interview	One month after emergence.	This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Ankara, Turkey