Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT04686058
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2020-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sedation Techniques for Outpatient Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D012996', 'term': 'Solutions'}], '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'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time taken to onset of sedation', 'timeFrame': 'From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced', 'description': 'Time taken for patient to reach a sedation score of MOAAS 3 or 4'}], 'primaryOutcomes': [{'measure': "Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)", 'timeFrame': 'From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery', 'description': 'Recovery of patient from sedation when MOAAS 5 is achieved'}, {'measure': 'Recovery time to ambulation', 'timeFrame': 'From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery', 'description': 'Recovery of patient from sedation when patient starts ambulating'}, {'measure': 'Recovery time to discharge', 'timeFrame': 'From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery', 'description': 'Recovery of patient from sedation when patient is deemed fit for discharge home'}, {'measure': 'Endoscopist satisfaction score', 'timeFrame': 'After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy', 'description': 'After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation', 'description': 'After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).'}, {'measure': 'Patient willingness to repeat the same sedation technique', 'timeFrame': 'From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery', 'description': 'Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future'}], 'secondaryOutcomes': [{'measure': 'Rescue analgesic drug requirement', 'timeFrame': 'From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation', 'description': 'Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy'}, {'measure': 'Total drug consumption', 'timeFrame': 'Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation', 'description': 'Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy'}, {'measure': 'Ease of colonoscopy score', 'timeFrame': 'during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy', 'description': 'endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy)'}, {'measure': 'Recalled events during colonoscopy', 'timeFrame': 'Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery', 'description': 'The number of recalled events during the entire duration of colonoscopy'}, {'measure': 'Recalled discomfort/ pain during colonoscopy', 'timeFrame': 'Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery', 'description': 'The number of recalled events of discomfor/pain during the entire duration of colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TCI propofol', 'PCS propofol', 'sedation', 'colonoscopy'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.', 'detailedDescription': 'This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II patients\n* aged between 18 to 80 years\n* scheduled for outpatient colonoscopy\n\nExclusion Criteria:\n\n* history of or with psychiatric disease\n* on psychoactive drugs\n* mentally or physically unable to use the hand-held device for PCS\n* previous complications from anaesthesia or sedation\n* potentially difficult airway maintenance\n* obstructive sleep apnoea\n* pregnant\n* with contraindications to the study drugs'}, 'identificationModule': {'nctId': 'NCT04686058', 'briefTitle': 'Sedation Techniques for Outpatient Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy', 'orgStudyIdInfo': {'id': 'FF-2014-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TCI propofol', 'description': "Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale", 'interventionNames': ['Drug: Propofol 10 MG/ML Injection', 'Device: target controlled infusion pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCS propofol', 'description': 'Patient-controlled sedation titrated by the patient to comfort level', 'interventionNames': ['Drug: Propofol 10 MG/ML Injection', 'Device: patient-controlled sedation pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'midazolam and pethidine', 'description': 'Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation', 'interventionNames': ['Drug: Midazolam injection', 'Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection']}], 'interventions': [{'name': 'Propofol 10 MG/ML Injection', 'type': 'DRUG', 'otherNames': ['propofol'], 'armGroupLabels': ['PCS propofol', 'TCI propofol']}, {'name': 'Midazolam injection', 'type': 'DRUG', 'otherNames': ['midazolam'], 'armGroupLabels': ['midazolam and pethidine']}, {'name': 'Pethidine Hydrochloride 50 Mg/mL Solution for Injection', 'type': 'DRUG', 'otherNames': ['pethidine'], 'armGroupLabels': ['midazolam and pethidine']}, {'name': 'target controlled infusion pump', 'type': 'DEVICE', 'otherNames': ['TCI'], 'armGroupLabels': ['TCI propofol']}, {'name': 'patient-controlled sedation pump', 'type': 'DEVICE', 'otherNames': ['PCS'], 'armGroupLabels': ['PCS propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Pusat Perubatan Universiti Kebangsaan Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator, consultant anaesthesiologist', 'investigatorFullName': 'Nadia Md Nor', 'investigatorAffiliation': 'Universiti Kebangsaan Malaysia Medical Centre'}}}}