To Investigate the Incidence and Causes of Awareness During General AnesthesiaNCT04697732
İntraoperative Awareness Under General Anesthesia
An observational study of To Investigate the Incidence and Causes of Awareness During General Anesthesia and To Investigate the of Dreaming During Anesthesia, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- 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
- What is being tested?
- General anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 30,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2012to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,
Who may be able to join
- ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University
Ankara
Bahattin Tuncali, +90 232 2411000, tuncali.bahattin@gmail.com
Yonca Ozvardar Pekcan, +90 232 2411000, yncapek@gmail.com
About this study
Official title: 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).
Read more
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
- Being tested
- General anesthesia
- Keywords
- intraoperative awareness, general anesthesia, dreaming, incidence
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
Also called Modified Brice Interview
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Brice interview
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.
Measured: One hour after emergence
Modified Brice interview
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.
Measured: Twenty four hour after emergence
Modified Brice interview
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.
Measured: One week after emergence
Modified Brice interview
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.
Measured: One month after emergence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start17 Jul 2012
- Primary completion17 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Incidence and Causes of Awareness During General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahattin Tuncali, Baskent University Ankara Hospital
- Investigators
- Bahattin Tuncali, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697732
- Sponsor's protocol ID
- KA12/154
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
PubMed 15333419Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
PubMed 10703802Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.
PubMed 8363069Ghoneim M. The trauma of awareness: history, clinical features, risk factors, and cost. Anesth Analg. 2010 Mar 1;110(3):666-7. doi: 10.1213/ANE.0b013e3181cb5dfa. No abstract available.
PubMed 20185645Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.
PubMed 11939910Mashour GA. Posttraumatic stress disorder after intraoperative awareness and high-risk surgery. Anesth Analg. 2010 Mar 1;110(3):668-70. doi: 10.1213/ANE.0b013e3181c35926. No abstract available.
PubMed 20185646Bischoff P, Rundshagen I. Awareness under general anesthesia. Dtsch Arztebl Int. 2011 Jan;108(1-2):1-7. doi: 10.3238/arztebl.2011.0001. Epub 2011 Jan 10.
PubMed 21285993Errando CL, Perez-Caballero P, Gelb AW, Sigl JC. Methodology, human factors, and incidence of intraoperative awareness. Acta Anaesthesiol Scand. 2010 Jul;54(6):781-3. doi: 10.1111/j.1399-6576.2010.02216.x. No abstract available.
PubMed 20618162Enlund M, Hassan HG. Intraoperative awareness: detected by the structured Brice interview? Acta Anaesthesiol Scand. 2002 Apr;46(4):345-9. doi: 10.1034/j.1399-6576.2002.460402.x.
PubMed 11952430Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.
PubMed 19561776American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
PubMed 16571982WINTERBOTTOM EH. Insufficient anaesthesia. Br Med J. 1950 Jan 28;1(4647):247. doi: 10.1136/bmj.1.4647.247-c. No abstract available.
PubMed 15404998Sandlin D. A closer look at bispectral index monitoring. J Perianesth Nurs. 2001 Dec;16(6):420-2. doi: 10.1053/jpan.2001.28748.
PubMed 11740782Ishizawa Y. Mechanisms of anesthetic actions and the brain. J Anesth. 2007;21(2):187-99. doi: 10.1007/s00540-006-0482-x. Epub 2007 May 30.
PubMed 17458649Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.
PubMed 10201677
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT04697732
- Acronym / sponsor ID
- KA12/154
- 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
- Keywords
- intraoperative awareness, general anesthesia, dreaming, incidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 17 Jul 2012 (actual)
- Primary completion
- 17 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients age above 18 years | – | Other: General anesthesiaASA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,
Key inclusion criteria (1 listed)
- ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaAlso: Modified Brice InterviewFollowing 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 | Adult patients age above 18 years |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 15333419Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
- Background: PubMed 10703802Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
- Background: PubMed 8363069Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.
- Background: PubMed 20185645Ghoneim M. The trauma of awareness: history, clinical features, risk factors, and cost. Anesth Analg. 2010 Mar 1;110(3):666-7. doi: 10.1213/ANE.0b013e3181cb5dfa. No abstract available.
- Background: PubMed 11939910Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.
- Background: PubMed 20185646Mashour GA. Posttraumatic stress disorder after intraoperative awareness and high-risk surgery. Anesth Analg. 2010 Mar 1;110(3):668-70. doi: 10.1213/ANE.0b013e3181c35926. No abstract available.
- Background: PubMed 21285993Bischoff P, Rundshagen I. Awareness under general anesthesia. Dtsch Arztebl Int. 2011 Jan;108(1-2):1-7. doi: 10.3238/arztebl.2011.0001. Epub 2011 Jan 10.
- Background: PubMed 20618162Errando CL, Perez-Caballero P, Gelb AW, Sigl JC. Methodology, human factors, and incidence of intraoperative awareness. Acta Anaesthesiol Scand. 2010 Jul;54(6):781-3. doi: 10.1111/j.1399-6576.2010.02216.x. No abstract available.
- Background: PubMed 11952430Enlund M, Hassan HG. Intraoperative awareness: detected by the structured Brice interview? Acta Anaesthesiol Scand. 2002 Apr;46(4):345-9. doi: 10.1034/j.1399-6576.2002.460402.x.
- Background: PubMed 19561776Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.
- Background: PubMed 16571982American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
- Background: PubMed 15404998WINTERBOTTOM EH. Insufficient anaesthesia. Br Med J. 1950 Jan 28;1(4647):247. doi: 10.1136/bmj.1.4647.247-c. No abstract available.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahattin Tuncali principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Investigate the Incidence and Causes of Awareness During General Anesthesia and To Investigate the of Dreaming During Anesthesia, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahattin Tuncali (+90 232 2411000 ext. 1085, tuncali.bahattin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Brice interview (time frame: One hour after emergence). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697732, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021; AzTrials last refreshed its copy on 27 Oct 2026.