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İntraoperative Awareness Under General Anesthesia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04697732
Enrollment
30000
Registered
2021-01-06
Start date
2012-07-17
Completion date
2022-12-31
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

intraoperative awareness, general anesthesia, dreaming, incidence

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.

Interventions

OTHERGeneral 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.

Sponsors

Baskent University Ankara Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Brice interviewOne hour after emergenceThis 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactBahattin Tuncali
tuncali.bahattin@gmail.com+90 232 2411000
Backup ContactYonca Ozvardar Pekcan
yncapek@gmail.com+90 232 2411000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026