Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-01 @ 12:08 AM
Study NCT ID:
NCT02733705
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2016-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2016-03-27', 'studyFirstSubmitQcDate': '2016-04-08', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assess using Numeric rating scale (NRS) score', 'timeFrame': '20 minutes'}], 'secondaryOutcomes': [{'measure': 'Number of participants with hypoxia defined as oxygen saturation <92%', 'timeFrame': '60 minutes', 'description': 'The investigators define hypoxia as oxygen saturation \\< 92%. The investigators will report as number of episode.'}, {'measure': 'Number of participants with hypotension, defined as systolic blood pressure <90 mmHg', 'timeFrame': '60 minutes', 'description': 'The investigators define hypotension as systolic blood pressure\\< 90 mmHg. The investigators will report as number of episode.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'TRUS biopsy'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '34229860', 'type': 'DERIVED', 'citation': 'Suksompong S, Limratana P, Saengsomsuan N, Wongsawang N, Chaikittisilpa N. Propofol with or without fentanyl for pain relief after transrectal ultrasound-guided prostate (TRUS-P) biopsy: a randomized controlled study. Braz J Anesthesiol. 2021 Jul-Aug;71(4):345-351. doi: 10.1016/j.bjane.2021.02.001. Epub 2021 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 year\n* Patient American society of anesthesiology physical status I-III.\n* Scheduled for Transrectal ultrasound-guided prostate biopsy\n* BMI equal to or less than 30 kg/cm2\n\nExclusion Criteria:\n\n* Known hypersensitivity to propofol or fentanyl\n* History of bleeding tendency\n* Known case of active anal or rectal disease\n* Unable to rate pain score\n* History of drug abuse\n* Chronic opioid use'}, 'identificationModule': {'nctId': 'NCT02733705', 'briefTitle': 'Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Randomised Controlled Trial Comparing Combined Intravenous Propofol and Fentanyl Versus Intravenous Propofol Alone for Sedation in Patients Undergoing Transrectal Ultrasound-guided (TRUS) Prostate Biopsy', 'orgStudyIdInfo': {'id': 'TRUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'normal saline IV plus propofol infusion', 'interventionNames': ['Other: Control', 'Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl', 'description': '0.5 mcg/kg ideal body weight IV plus propofol infusion', 'interventionNames': ['Drug: Fentanyl', 'Drug: propofol']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'normal saline IV', 'armGroupLabels': ['Control']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'fentanyl 0.5 mcg/kg ideal BW', 'armGroupLabels': ['Fentanyl']}, {'name': 'propofol', 'type': 'DRUG', 'description': 'propofol infusion', 'armGroupLabels': ['Control', 'Fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Sirilak Suksompong', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sirilak Suksompong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sirilak Suksompong', 'investigatorAffiliation': 'Mahidol University'}}}}