İntraoperative Awareness Under General Anesthesia

January 5, 2021 updated by: Bahattin Tuncali, Baskent University Ankara Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30000

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

  • Name: Yonca Özvardar Pekcan
  • Phone Number: 1085 +90 232 2411000
  • Email: yncapek@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Başkent University
        • 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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,

Description

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 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
Intervention / Treatment
Adult patients age above 18 years
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.
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.
Other Names:
  • Modified Brice Interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Brice interview
Time Frame: One hour 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.
One hour after emergence
Modified Brice interview
Time Frame: Twenty four hour 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.
Twenty four hour after emergence
Modified Brice interview
Time Frame: One week 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.
One week after emergence
Modified Brice interview
Time Frame: 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.
One month after emergence.

Collaborators and Investigators

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

Sponsor

Baskent University Ankara Hospital

Investigators

  • Principal Investigator: Bahattin Tuncali, Başkent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 17, 2012

Primary Completion (Anticipated)

July 17, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA12/154

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

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.

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