Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04697732
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
İntraoperative Awareness Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058926', 'term': 'Intraoperative Awareness'}], 'ancestors': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Brice interview', 'timeFrame': 'One hour after emergence', 'description': '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.'}, {'measure': 'Modified Brice interview', 'timeFrame': 'Twenty four hour after emergence', 'description': '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.'}, {'measure': 'Modified Brice interview', 'timeFrame': 'One week after emergence', 'description': '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.'}, {'measure': 'Modified Brice interview', 'timeFrame': 'One month after emergence.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraoperative awareness', 'general anesthesia', 'dreaming', 'incidence'], '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']}, 'referencesModule': {'references': [{'pmid': '15333419', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10703802', 'type': 'BACKGROUND', 'citation': 'Sandin 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.'}, {'pmid': '8363069', 'type': 'BACKGROUND', 'citation': 'Moerman 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.'}, {'pmid': '20185645', 'type': 'BACKGROUND', 'citation': 'Ghoneim 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.'}, {'pmid': '11939910', 'type': 'BACKGROUND', 'citation': 'Lennmarken 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.'}, {'pmid': '20185646', 'type': 'BACKGROUND', 'citation': 'Mashour 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.'}, {'pmid': '21285993', 'type': 'BACKGROUND', 'citation': 'Bischoff 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.'}, {'pmid': '20618162', 'type': 'BACKGROUND', 'citation': 'Errando 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.'}, {'pmid': '11952430', 'type': 'BACKGROUND', 'citation': 'Enlund 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.'}, {'pmid': '19561776', 'type': 'BACKGROUND', 'citation': 'Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.'}, {'pmid': '16571982', 'type': 'BACKGROUND', 'citation': 'American 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.'}, {'pmid': '15404998', 'type': 'BACKGROUND', 'citation': 'WINTERBOTTOM EH. Insufficient anaesthesia. Br Med J. 1950 Jan 28;1(4647):247. doi: 10.1136/bmj.1.4647.247-c. No abstract available.'}, {'pmid': '11740782', 'type': 'BACKGROUND', 'citation': 'Sandlin D. A closer look at bispectral index monitoring. J Perianesth Nurs. 2001 Dec;16(6):420-2. doi: 10.1053/jpan.2001.28748.'}, {'pmid': '17458649', 'type': 'BACKGROUND', 'citation': 'Ishizawa 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.'}, {'pmid': '10201677', 'type': 'BACKGROUND', 'citation': 'Domino 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.'}, {'pmid': '19496761', 'type': 'BACKGROUND', 'citation': 'Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiol Scand. 2009 Aug;53(7):873-82. doi: 10.1111/j.1399-6576.2009.02016.x. Epub 2009 Jun 3.'}, {'pmid': '18515816', 'type': 'BACKGROUND', 'citation': 'Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM, Soriano JL, Chaves S, Gil F, Garcia-Aguado R. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. Br J Anaesth. 2008 Aug;101(2):178-85. doi: 10.1093/bja/aen144. Epub 2008 May 30.'}, {'pmid': '17264720', 'type': 'BACKGROUND', 'citation': "Pollard RJ, Coyle JP, Gilbert RL, Beck JE. Intraoperative awareness in a regional medical system: a review of 3 years' data. Anesthesiology. 2007 Feb;106(2):269-74. doi: 10.1097/00000542-200702000-00014."}, {'pmid': '15172773', 'type': 'BACKGROUND', 'citation': 'Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.'}, {'pmid': '14674969', 'type': 'BACKGROUND', 'citation': 'Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.'}, {'pmid': '12088946', 'type': 'BACKGROUND', 'citation': 'Wennervirta J, Ranta SO, Hynynen M. Awareness and recall in outpatient anesthesia. Anesth Analg. 2002 Jul;95(1):72-7, table of contents. doi: 10.1097/00000539-200207000-00013.'}, {'pmid': '9585303', 'type': 'BACKGROUND', 'citation': 'Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.'}, {'pmid': '9311394', 'type': 'BACKGROUND', 'citation': 'Nordstrom O, Engstrom AM, Persson S, Sandin R. Incidence of awareness in total i.v. anaesthesia based on propofol, alfentanil and neuromuscular blockade. Acta Anaesthesiol Scand. 1997 Sep;41(8):978-84. doi: 10.1111/j.1399-6576.1997.tb04823.x.'}, {'pmid': '9602573', 'type': 'BACKGROUND', 'citation': "Schwender D, Kunze-Kronawitter H, Dietrich P, Klasing S, Forst H, Madler C. Conscious awareness during general anaesthesia: patients' perceptions, emotions, cognition and reactions. Br J Anaesth. 1998 Feb;80(2):133-9. doi: 10.1093/bja/80.2.133."}, {'pmid': '9788027', 'type': 'BACKGROUND', 'citation': 'Osterman JE, van der Kolk BA. Awareness during anesthesia and posttraumatic stress disorder. Gen Hosp Psychiatry. 1998 Sep;20(5):274-81. doi: 10.1016/s0163-8343(98)00035-8.'}, {'type': 'BACKGROUND', 'citation': 'Forman S. Awareness during general anesthesia: Concepts and controversies. Periop Med and Pain 2006; 25: 211-218'}, {'pmid': '20661203', 'type': 'BACKGROUND', 'citation': 'Leslie K, Davidson AJ. Awareness during anesthesia: a problem without solutions? Minerva Anestesiol. 2010 Aug;76(8):624-8.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAdult 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).\n\nDescriptive 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.\n\nWe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,\n\nExclusion Criteria:\n\n* ASA V patients\n* Patients below 18 years of age,\n* Patient who can not give informed consent,\n* Patients who have known psychological or psychiatric problems,\n* Patients who are not suitable for postoperative follow-up'}, 'identificationModule': {'nctId': 'NCT04697732', 'briefTitle': 'İntraoperative Awareness Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University Ankara Hospital'}, 'officialTitle': 'The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'KA12/154'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients age above 18 years', 'description': '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.', 'interventionNames': ['Other: General anesthesia']}], 'interventions': [{'name': 'General anesthesia', 'type': 'OTHER', 'otherNames': ['Modified Brice Interview'], 'description': '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.', 'armGroupLabels': ['Adult patients age above 18 years']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Bahattin Tuncali', 'role': 'CONTACT', 'email': 'tuncali.bahattin@gmail.com', 'phone': '+90 232 2411000'}, {'name': 'Yonca Ozvardar Pekcan', 'role': 'CONTACT', 'email': 'yncapek@gmail.com', 'phone': '+90 232 2411000'}], 'facility': 'Baskent University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Bahattin Tuncali', 'role': 'CONTACT', 'email': 'tuncali.bahattin@gmail.com', 'phone': '+90 232 2411000', 'phoneExt': '1085'}, {'name': 'Yonca Ozvardar Pekcan', 'role': 'CONTACT', 'email': 'yncapek@gmail.com', 'phone': '+90 232 2411000', 'phoneExt': '1085'}], 'overallOfficials': [{'name': 'Bahattin Tuncali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University Ankara Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, MD', 'investigatorFullName': 'Bahattin Tuncali', 'investigatorAffiliation': 'Baskent University Ankara Hospital'}}}}