Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT06409104
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 101 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP.\n* To study both agents effect on respiratory complications.\n* To demonstrate the effect of both drugs on cognitive functions.\n* To assess the effect of both drugs on duration of procedure and number of interruptions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-12', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral Index sedation Score', 'timeFrame': 'intraoperative', 'description': '\\>90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate during procedure', 'timeFrame': 'intraoperative', 'description': 'Change in heart rate during procedure'}, {'measure': 'Change in MAP', 'timeFrame': 'intraoperative', 'description': 'Change in MAP during procedure'}, {'measure': 'Pain during procedure according to Facial Pain Rating Scale', 'timeFrame': 'first 2hours postoperative', 'description': 'Pain during procedure according to Facial Pain Rating Scale (FPS;0 no pain-10 maximum pain)'}, {'measure': 'Duration to recovery after the end of procedure', 'timeFrame': 'first 2hours postoperative', 'description': 'Duration to recovery after the end of procedure'}, {'measure': 'Total doses of both agents used', 'timeFrame': 'intraoperative', 'description': 'Total doses of Propofol or Dexmedetomidine used'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'Endoscopic', 'cancer', 'sedation', 'propofol', 'Dexmedetomidine'], 'conditions': ['Sedation in ERCP']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.', 'detailedDescription': 'Endoscopic retrograde cholangiopancreatography (ERCP) plays a crucial role in the diagnosis and treatment of pancreaticobiliary pathologies, and its use has increased in recent years. The procedure lasts from 30 to 60 position. Patients usually cannot tolerate the procedure because of pain, uncomfortable position, fear, and nausea without adequate sedation; therefore, ERCP is generally performed under moderate to deep sedation or even GA. ERCP under general anesthesia has several limitations. The procedure is often prolonged due to extra time required for patient preparation, induction of anesthesia, tracheal intubation, and recovery. In addition, the cost per procedure is higher. Deep sedation, on the other hand, is an alternative that is used by specific centers under anesthesiologist supervision instead of general anesthesia. Deep sedation has the advantage of offering the extra time required for general anesthesia and better procedure conditions in relation to conscious sedation.\n\nPropofol is a popular drug that is frequently used in day surgery because of its early onset activity, short duration of action, and the fact that the patient regains normal mental functions only minutes after intravenous application. However, an increased dose of propofol may cause undesirable side effects such as hypoxia which is a common occurrence during upper GI endoscopy under sedation with propofol prolonged hypoxia is the most common cause of cardiac arrhythmia and coronary ischemia .Also, propofol lacks adequate analgesic effects to inhibit visceral traction, pain other side effects of propofol include hypotension and apnea.\n\nIn recent years, dexmedetomidine has been used as an alternative to Propofol in conscious sedation applications. Because it provides sedation and analgesia but does not cause respiratory depression, dexmedetomidine is considered a suitable drug for operations that are performed under local anesthesia.\n\nAccording to authors best knowledge, there are no enough studies comparing both drugs in patients undergoing ERCP\n\nAim of the work The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.\n\nObjectives:\n\n* To compare the hemodynamic profile of dexmedetomidine and Propofol during sedation in patients undergoing ERCP.\n* To study both agents effect on respiratory complications.\n* To demonstrate the effect of both drugs on cognitive functions.\n* To assess the effect of both drugs on the duration of the procedure and the number of interruptions.\n\nHypothesis:\n\nThe investigators hypothesize that dexmedetomidine will provide better sedation and analgesia with fewer side effects when compared to propofol in patients undergoing ERCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age starting from 21 to 60 years.\n* Genders eligible for study: males and females\n* ASA II-III\n* Undergoing ERCP\n* 18.5 to 30 kg/m2\n\nExclusion Criteria:\n\n* Patient refusal\n* Known allergy to drugs used in the study.\n* Use of any anti-coagulants\n* Neurological disorders\n* Advanced liver or kidney disease\n* Patient with psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT06409104', 'briefTitle': 'Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study', 'orgStudyIdInfo': {'id': 'MS-211-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion .', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion', 'armGroupLabels': ['Propofol']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion.', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Ahmed Mohamed Soliman', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}