Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 11:21 AM
Study NCT ID:
NCT04235894
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2020-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005149', 'term': 'Facial Expression'}, {'id': 'D012904', 'term': 'Smiling'}], 'ancestors': [{'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2020-01-01', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observer rating score after the procedure', 'timeFrame': 'On the emergence of anesthesia, max. 2 hours after start of anesthesia', 'description': "On the emergence of anesthesia, Observer's: rating of facial expression was written (-3: loud expression of pain; -2: painful grimace; -1: dissatisfaction; 0: neutral; 1: satisfaction; 2: smile and 3: laughter)"}], 'secondaryOutcomes': [{'measure': 'Bispectral index values during the procedure', 'timeFrame': 'During the propofol anesthesia, max. 2 hours after start of anesthesia', 'description': 'Bispectral index (BIS) was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.'}, {'measure': 'Blood pressure values during the procedure', 'timeFrame': 'During the propofol anesthesia, max. 2 hours after start of anesthesia', 'description': 'Blood pressure value was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.'}, {'measure': 'Pulse values during the procedure', 'timeFrame': 'During the propofol anesthesia, max. 2 hours after start of anesthesia', 'description': 'Pulse value was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Propofol;', 'Endoscopy, Gastrointestinal;', 'Dreams;', 'Facial expression;', 'Smiling'], 'conditions': ['Anesthesia', 'Propofol', 'Drug Effect']}, 'referencesModule': {'references': [{'pmid': '28915133', 'type': 'BACKGROUND', 'citation': 'Leslie K, Kave B. Complications and unplanned admissions in nonoperating room procedures. Curr Opin Anaesthesiol. 2017 Dec;30(6):658-662. doi: 10.1097/ACO.0000000000000519.'}, {'pmid': '23308191', 'type': 'BACKGROUND', 'citation': 'Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One. 2013;8(1):e53311. doi: 10.1371/journal.pone.0053311. Epub 2013 Jan 8.'}, {'pmid': '27366543', 'type': 'BACKGROUND', 'citation': 'Koroglu G, Tezcan AH. A Case Report of the First Propofol Addiction in Turkey. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):434-6. doi: 10.5152/TJAR.2015.54872. Epub 2015 Dec 1.'}, {'pmid': '20950316', 'type': 'BACKGROUND', 'citation': 'Levy RJ. Clinical effects and lethal and forensic aspects of propofol. J Forensic Sci. 2011 Jan;56 Suppl 1(0 1):S142-7. doi: 10.1111/j.1556-4029.2010.01583.x. Epub 2010 Oct 15.'}, {'pmid': '20679780', 'type': 'BACKGROUND', 'citation': 'Ellett ML. Review of propofol and auxiliary medications used for sedation. Gastroenterol Nurs. 2010 Jul-Aug;33(4):284-95; quiz 296-7. doi: 10.1097/SGA.0b013e3181eac371.'}, {'pmid': '21239913', 'type': 'BACKGROUND', 'citation': 'Bryson EO, Frost EA. Propofol abuse. Int Anesthesiol Clin. 2011 Winter;49(1):173-80. doi: 10.1097/AIA.0b013e3181f2bcb0. No abstract available.'}, {'pmid': '22807612', 'type': 'BACKGROUND', 'citation': 'Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Ichise Y, Tanaka N. Safety and effectiveness of propofol sedation during and after outpatient colonoscopy. World J Gastroenterol. 2012 Jul 14;18(26):3420-5. doi: 10.3748/wjg.v18.i26.3420.'}, {'pmid': '25674117', 'type': 'BACKGROUND', 'citation': 'Tezcan AH, Ornek DH, Ozlu O, Baydar M, Yavuz N, Ozaslan NG, Dilek K, Keske A. Abuse potential assessment of propofol by its subjective effects after sedation. Pak J Med Sci. 2014 Nov-Dec;30(6):1247-52. doi: 10.12669/pjms.306.5811.'}, {'pmid': '17868199', 'type': 'BACKGROUND', 'citation': 'Roussin A, Montastruc JL, Lapeyre-Mestre M. Pharmacological and clinical evidences on the potential for abuse and dependence of propofol: a review of the literature. Fundam Clin Pharmacol. 2007 Oct;21(5):459-66. doi: 10.1111/j.1472-8206.2007.00497.x.'}, {'pmid': '26634074', 'type': 'BACKGROUND', 'citation': 'Jeon YT. Propofol as a controlled substance: poison or remedy. Korean J Anesthesiol. 2015 Dec;68(6):525-6. doi: 10.4097/kjae.2015.68.6.525. Epub 2015 Nov 25. No abstract available.'}, {'pmid': '18853587', 'type': 'BACKGROUND', 'citation': 'Stait ML, Leslie K, Bailey R. Dreaming and recall during sedation for colonoscopy. Anaesth Intensive Care. 2008 Sep;36(5):685-90. doi: 10.1177/0310057X0803600509.'}, {'pmid': '23863717', 'type': 'BACKGROUND', 'citation': 'Xu G, Liu X, Sheng Q, Yu F, Wang K. Sex differences in dreaming during short propofol sedation for upper gastrointestinal endoscopy. Neuroreport. 2013 Oct 2;24(14):797-802. doi: 10.1097/WNR.0b013e3283644b66.'}, {'pmid': '25685056', 'type': 'BACKGROUND', 'citation': 'Gyulahazi J, Varga K, Igloi E, Redl P, Kormos J, Fulesdi B. The effect of preoperative suggestions on perioperative dreams and dream recalls after administration of different general anesthetic combinations: a randomized trial in maxillofacial surgery. BMC Anesthesiol. 2015 Jan 28;15(1):11. doi: 10.1186/1471-2253-15-11. eCollection 2015.'}, {'pmid': '25197107', 'type': 'BACKGROUND', 'citation': 'Bagchi D, Mandal MC, Basu SR. Arousal time from sedation during spinal anaesthesia for elective infraumbilical surgeries: Comparison between propofol and midazolam. Indian J Anaesth. 2014 Jul;58(4):403-9. doi: 10.4103/0019-5049.138972.'}, {'pmid': '29108303', 'type': 'BACKGROUND', 'citation': 'Cascella M, Fusco R, Caliendo D, Granata V, Carbone D, Muzio MR, Laurelli G, Greggi S, Falcone F, Forte CA, Cuomo A. Anesthetic dreaming, anesthesia awareness and patient satisfaction after deep sedation with propofol target controlled infusion: A prospective cohort study of patients undergoing day case breast surgery. Oncotarget. 2017 Apr 19;8(45):79248-79256. doi: 10.18632/oncotarget.17238. eCollection 2017 Oct 3.'}, {'pmid': '19528807', 'type': 'BACKGROUND', 'citation': 'Eer AS, Padmanabhan U, Leslie K. Propofol dose and incidence of dreaming during sedation. Eur J Anaesthesiol. 2009 Oct;26(10):833-6. doi: 10.1097/EJA.0b013e32832c500c.'}, {'pmid': '24733993', 'type': 'BACKGROUND', 'citation': 'Rosenberg RS, Van Hout S. The American Academy of Sleep Medicine Inter-scorer Reliability program: respiratory events. J Clin Sleep Med. 2014 Apr 15;10(4):447-54. doi: 10.5664/jcsm.3630.'}, {'pmid': '28575720', 'type': 'BACKGROUND', 'citation': 'Siclari F, Tononi G. Local aspects of sleep and wakefulness. Curr Opin Neurobiol. 2017 Jun;44:222-227. doi: 10.1016/j.conb.2017.05.008. Epub 2017 May 30.'}, {'pmid': '35056370', 'type': 'DERIVED', 'citation': 'Matus H, Kvolik S, Rakipovic A, Borzan V. Bispectral Index Monitoring and Observer Rating Scale Correlate with Dreaming during Propofol Anesthesia for Gastrointestinal Endoscopies. Medicina (Kaunas). 2021 Dec 31;58(1):62. doi: 10.3390/medicina58010062.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates correlation between dreaming in propofol anesthesia and an Observer-rating-scale of facial expression after gastrointestinal endoscopy in adults. It also compares dreamers and non-dreamers in age, BMI, propofol dose, duration of procedure, mean arterial pressure, pulse values and Bispectral index values.', 'detailedDescription': "After Ethical committee approval and written informed consent was obtained, a total of 124 patients undergoing gastrointestinal endoscopy were recruited in the prospective observational study. Anesthesia was maintained using incremental propofol doses until the patient was calm and unresponsive to painful stimuli. Bispectral Index (BIS), blood pressure (BP) and pulse were monitored in typical intervals: before induction, during induction, at the beginning of the procedure, at 2nd, 5th and 10th minute of the procedure, and on emergence. On the emergence of anesthesia, the patient's facial expression was rated numerically (-3 pain, +3 smile). Thereafter patients were asked to rate their dream."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive male and female adult patients undergoing gastrointestinal endoscopy at Osijek University Hsspital who wrote informad consent and were able to understand study protocol.\n\nPatients younger than 18 years, those allergic to propofol and unable to understand study protocol were not included in the study. patients with procedures lasting less than 5 minutes and more than 60 minutes were excluded from the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients undergoing gastrointestinal endoscopy at Osijek University HOspital form September 2016 to October 2017.\n\nExclusion Criteria:\n\n* . Patients who were younger than 18 years, unscheduled patients who were not hemodynamically stable, those who were not able to understand study protocol, and who did not sign written informed consent were not included in the study. Patients whose procedure was longer than 60 minutes and patients with incomplete records were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04235894', 'briefTitle': 'An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Osijek University Hospital'}, 'officialTitle': 'An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia', 'orgStudyIdInfo': {'id': 'Osijek UH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing GI endoscopy at Osijek University Hospital', 'description': "Observational study. A total of 130 consecutive patients undergoing gastrointestinal endoscopy were included. The anesthesia was provided with propofol, starting with 0,5 mg/kg, and titrated until a patient was unresponsive to painful stimuli and maintaining spontaneous breathing. The blood pressure, pulse and Bispectral index values were measured in 6 defined points. On the emergence from anesthesia, the patient's facial expression was rated numerically by the investigator.", 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Intravenous anesthesia with propofol started with 0.5 mg kg-1, and was titrated until a patient was unresponsive to painful stimuli \\& maintaining spontaneous breathing during gastrointestinal endoscopy', 'armGroupLabels': ['Patients undergoing GI endoscopy at Osijek University Hospital']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Helena Matus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of emergency medicine, Brodsko-posavska county; Croatia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osijek University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Josip Juraj Strossmayer University of Osijek', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}