Nctid:
NCT06614010
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011595", "term"=>"Psychomotor Agitation"}, {"id"=>"D000071257", "term"=>"Emergence Delirium"}], "ancestors"=>[{"id"=>"D000020820", "term"=>"Dyskinesias"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000011596", "term"=>"Psychomotor Disorders"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000096762", "term"=>"Aberrant Motor Behavior in Dementia"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D000003693", "term"=>"Delirium"}, {"id"=>"D000003221", "term"=>"Confusion"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M772", "name"=>"Emergence Delirium", "asFound"=>"Emergence Agitation", "relevance"=>"HIGH"}, {"id"=>"M14452", "name"=>"Psychomotor Agitation", "asFound"=>"Agitation", "relevance"=>"HIGH"}, {"id"=>"M6894", "name"=>"Delirium", "relevance"=>"LOW"}, {"id"=>"M22574", "name"=>"Dyskinesias", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M14453", "name"=>"Psychomotor Disorders", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M6904", "name"=>"Dementia", "relevance"=>"LOW"}, {"id"=>"M3259", "name"=>"Aberrant Motor Behavior in Dementia", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M6446", "name"=>"Confusion", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000020927", "term"=>"Dexmedetomidine"}, {"id"=>"D000077212", "term"=>"Ropivacaine"}], "ancestors"=>[{"id"=>"D000006993", "term"=>"Hypnotics and Sedatives"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000058647", "term"=>"Adrenergic alpha-2 Receptor Agonists"}, {"id"=>"D000000316", "term"=>"Adrenergic alpha-Agonists"}, {"id"=>"D000000322", "term"=>"Adrenergic Agonists"}, {"id"=>"D000018663", "term"=>"Adrenergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}], "browseLeaves"=>[{"id"=>"M22662", "name"=>"Dexmedetomidine", "asFound"=>"Human", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M1700", "name"=>"Ropivacaine", "asFound"=>"Stress", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M7992", "name"=>"Epinephrine", "relevance"=>"LOW"}, {"id"=>"M30371", "name"=>"Racepinephrine", "relevance"=>"LOW"}, {"id"=>"M211043", "name"=>"Epinephryl borate", "relevance"=>"LOW"}, {"id"=>"M10043", "name"=>"Hypnotics and Sedatives", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M3668", "name"=>"Adrenergic alpha-Agonists", "relevance"=>"LOW"}, {"id"=>"M3673", "name"=>"Adrenergic Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>207}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-02-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of awakening agitation", "timeFrame"=>"postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU", "description"=>"Riker sedation-agitation scale (SAS) scores were recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU for each group. These scores were used to evaluate the sedation and agitation status of the patients."}], "secondaryOutcomes"=>[{"measure"=>"Analgesic effect", "timeFrame"=>"postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU", "description"=>"The analgesic effect was recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU for each group. Analgesia was assessed using the Numerical Rating Scale (NRS), which ranges from 0 to 10, with higher scores indicating more severe pain."}, {"measure"=>"Ramesay score", "timeFrame"=>"postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU", "description"=>"The sedation effect of patients in each group was recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU. Sedation was assessed using the Ramsay scale, which consists of 6 grades, with higher scores indicating deeper levels of sedation."}, {"measure"=>"Hemodynamic parameters", "timeFrame"=>"During operation", "description"=>"Comparisons of hemodynamic parameters among the three groups were made at several time points: after admission (T0), upon completion of anesthesia induction (T1), at the start of surgery (T2), one hour into the surgery (T3), at the end of surgery (T4), and at the removal of the laryngeal mask (T5). The parameters assessed included changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen saturation (SpO2)."}, {"measure"=>"Record of laryngeal mask removal time and adverse reactions", "timeFrame"=>"Within 24 hours after surgery", "description"=>"The time of laryngeal mask removal was documented in detail for all three patient groups. Additionally, attention was given to monitoring and recording any adverse reactions occurring during the perioperative period."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Fascia Iliaca Block", "Dexmedetomidine", "Emergence Agitation", "Ropivacaine", "Analgesic Mechanism"], "conditions"=>["Dexmedetomidine", "Fascia Iliaca Block"]}, "descriptionModule"=>{"briefSummary"=>"To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. age between 18 and 65 years, with no restriction on gender\n2. diagnosis of hip joint disease necessitating hip arthroplasty\n3. ASA grade I-II\n4. no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation\n5. no history of psychiatric disorders or long-term use of sedative medications prior to the operation\n6. signing of an informed consent form to voluntarily participate in the study.\n\nExclusion Criteria:\n\n1. patients allergic to or with contraindications to ropivacaine or dexmedetomidine\n2. patients exhibiting symptoms of agitation or delirium prior to the procedure\n3. patients with severe central or peripheral nervous system disorders\n4. patients with coagulation disorders or receiving anticoagulant therapy\n5. pregnant or breastfeeding women\n6. patients who received other medications or treatments prior to the procedure that might affect the study results\n7. patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block"}, "identificationModule"=>{"nctId"=>"NCT06614010", "briefTitle"=>"Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Qianfoshan Hospital"}, "officialTitle"=>"Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery", "orgStudyIdInfo"=>{"id"=>"LI"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group S1", "description"=>"Before anesthesia induction, an iliac fascia block was administered using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, dexmedetomidine was infused intravenously at a rate of 0.5 µg/kg/h.", "interventionNames"=>["Drug: Dexmedetomidine Injection"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group S2", "description"=>"Before anesthesia induction, an iliac fascia block was administered using a mixture of 0.375% ropivacaine and 1ug/kg dexmedetomidine (30ml) under ultrasound guidance. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.", "interventionNames"=>["Drug: Ropivacaine and Dexmedetomidine"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group C", "description"=>"Before anesthesia induction, an iliac fascia block was performed using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.", "interventionNames"=>["Drug: Sodium Chloride Injection"]}], "interventions"=>[{"name"=>"Dexmedetomidine Injection", "type"=>"DRUG", "description"=>"Before anesthesia induction, an iliac fascia block was administered using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, dexmedetomidine was infused intravenously at a rate of 0.5 µg/kg/h.", "armGroupLabels"=>["Group S1"]}, {"name"=>"Ropivacaine and Dexmedetomidine", "type"=>"DRUG", "description"=>"Before anesthesia induction, an iliac fascia block was administered using a mixture of 0.375% ropivacaine and 1ug/kg dexmedetomidine (30ml) under ultrasound guidance. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.", "armGroupLabels"=>["Group S2"]}, {"name"=>"Sodium Chloride Injection", "type"=>"DRUG", "description"=>"Before anesthesia induction, an iliac fascia block was performed using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.", "armGroupLabels"=>["Group C"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"250000", "city"=>"Jinan", "state"=>"Shandong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Pengcai Shi, Chief physician", "role"=>"CONTACT", "email"=>"shipc1997@163.com", "phone"=>"86+13791126828"}], "facility"=>"Qianfoshan Hospital", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}], "centralContacts"=>[{"name"=>"Pengcai Shi, Chief physician", "role"=>"CONTACT", "email"=>"shipc1997@163.com", "phone"=>"13791126828"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Qianfoshan Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Chief physician，Master Tutor", "investigatorFullName"=>"Pengcai Shi", "investigatorAffiliation"=>"Qianfoshan Hospital"}}}}
