Nctid:
NCT06227143
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000777", "term"=>"Anesthetics"}], "ancestors"=>[{"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M10674", "name"=>"Ketamine", "relevance"=>"LOW"}, {"id"=>"M18307", "name"=>"Propofol", "relevance"=>"LOW"}, {"id"=>"M22662", "name"=>"Dexmedetomidine", "relevance"=>"LOW"}, {"id"=>"M11014", "name"=>"Lidocaine", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "asFound"=>"Saline", "relevance"=>"HIGH"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M1673", "name"=>"Sevoflurane", "relevance"=>"LOW"}, {"id"=>"M13020", "name"=>"Oxycodone", "relevance"=>"LOW"}, {"id"=>"M4909", "name"=>"Betamethasone", "relevance"=>"LOW"}, {"id"=>"M1696", "name"=>"Remifentanil", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-04-09", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Density Spectral Array (DSA)", "timeFrame"=>"20 minute during steady state peroperative anesthesia", "description"=>"Descriptive comparison of DSA appearance during opioid-free anesthesia, target controlled and volatile anesthesia"}], "primaryOutcomes"=>[{"measure"=>"Patient state index level (PSI)", "timeFrame"=>"20 minute during steady state peroperative anesthesia", "description"=>"Difference in PSI levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis"}], "secondaryOutcomes"=>[{"measure"=>"Spectral edge frequency (SEF)", "timeFrame"=>"20 minute during steady state peroperative anesthesia", "description"=>"Difference in SEF levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Opioid-free Anesthesia", "Anesthesia Depth Monitoring"]}, "descriptionModule"=>{"briefSummary"=>"Opioid-free anesthesia is feasible and effective but still not common practice. Anesthesia depth monitoring is not investigated for use in anesthesia combining low dose infusions of several drugs with different sedative patterns on EEG. This is an observational study comparing opioid-free anesthesia with regular anesthesia in regards to DSA, SEF and PSI from the Sedline monitor.", "detailedDescription"=>"Patients who undergo general anaesthesia are more or less extensively monitored, with the sole purpose of surveilling depth of anesthesia and nociception. Parameters such as heart rate, blood pressure, pupillary size and sweating has historically been used as predictive markers for this surveillance. However, these clinical parameters have low predictive capacity and there is a tendency to overdue perioperative sedation and misinterpret sympathetically derived reactions as pain. This could lead to higher incidence of postoperative delirium and opioid induced hyperalgesia. On the contrary, an overestimated trust in the mentioned parameters might lead to increased risk of intra-operative awareness.\n\nThe usefulness of processed encephalography (pEEG) during anesthesia has since long been promoted for anesthesia providers. Since then, several commercial devices has been developed and deployed for clinical use. Although mixed results are presented in clinical studies there is now a significant empirical experience for its use in routine anesthesia with volatile anesthetics and propofol. Density spectral array (DSA) is the latest contribution in the field of encephalographic monitoring. It is a two-dimensional graph plotting the power of each frequency-interval on a time-scale.\n\nMore and more data on the effectiveness and safety of opioid free anaesthesia (OFA) have been released, especially as a direct result of the ongoing opioid-epidemic affecting a large number of people worldwide. The algorithms for the commercial devices, using DSA, has to this date not been validated for multimodal anesthetic regimens using ketamine and dexmedetomidine.\n\nThe purpose of this observational study is to compare DSA pattern and data for pEEG between OFA and total intravenous anaesthesia or general anaesthesia with volatile anesthetics for patients undergoing laparoscopic surgery."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Adult patients undergoing laparoscopic surgery under general anesthesia with different protocol-based anesthetic methods (opioid-free, intravenous target controlled or volatile) included after written and oral consent.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Elective laparoscopic surgery\n* Adult patients\n* Ability to accomodate verbal and written information in swedish\n* Voluntary\n\nExclusion Criteria:\n\n* Pregnancy\n* Intolerance to NSAID"}, "identificationModule"=>{"nctId"=>"NCT06227143", "briefTitle"=>"Anesthesia Depth During Opioid Free Anesthesia", "organization"=>{"class"=>"OTHER", "fullName"=>"Region Halland"}, "officialTitle"=>"Monitoring Depth of Anesthesia During Opioid Free Anesthesia", "orgStudyIdInfo"=>{"id"=>"2022-07156-02"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Opioid-free anesthesia", "description"=>"Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia:\n\nKetamine Dexmedetomidine Propofol Sevoflurane Lidocaine Betamethasone Paracetamol NSAID", "interventionNames"=>["Procedure: Anesthesia depth monitoring"]}, {"label"=>"Target Controlled Infusion", "description"=>"Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia:\n\nPropofol Remifentanil Oxycodone Paracetamol NSAID Bethametasone", "interventionNames"=>["Procedure: Anesthesia depth monitoring"]}, {"label"=>"Volatile anesthetics", "description"=>"Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia:\n\nSevoflurane Propofol Remifentanil Oxycodone Paracetmol NSAID Bethametasone", "interventionNames"=>["Procedure: Anesthesia depth monitoring"]}], "interventions"=>[{"name"=>"Anesthesia depth monitoring", "type"=>"PROCEDURE", "description"=>"Anesthesia depth monitoring during opioid-free anesthesia", "armGroupLabels"=>["Opioid-free anesthesia", "Target Controlled Infusion", "Volatile anesthetics"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"30582", "city"=>"Halmstad", "state"=>"Halland", "country"=>"Sweden", "facility"=>"Halland Hospital Halmstad", "geoPoint"=>{"lat"=>56.67446, "lon"=>12.85676}}], "overallOfficials"=>[{"name"=>"Krister Mogianos, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Region Halland"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"Project plan. Individual measurements. Statistical analysis."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Region Halland", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine", "investigatorFullName"=>"Anna Persson", "investigatorAffiliation"=>"Region Halland"}}}}
