Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-02 @ 1:13 PM
Study NCT ID:
NCT03812003
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Breast cancer patient'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2019-01-13', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)', 'timeFrame': '0 minutes', 'description': '1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': '1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'The amount analgesic requirement in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': '1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR'}], 'secondaryOutcomes': [{'measure': 'degree of post-operative nausea in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the degree of nausea in PAR: mild, moderate, severe'}, {'measure': 'degree of post-operative vomiting in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the degree of vomiting in PAR: mild, moderate, severe'}, {'measure': 'post-operative blood pressure in post-anesthesia room (PAR)', 'timeFrame': '0 minutes', 'description': 'Record the blood pressure(mmHg) in PAR'}, {'measure': 'post-operative systolic blood pressure in post-anesthesia room (PAR)', 'timeFrame': '0 minutes', 'description': 'Record the systolic blood pressure(mmHg) in PAR'}, {'measure': 'post-operative systolic blood pressure in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the systolic blood pressure(mmHg) in PAR'}, {'measure': 'post-operative diastolic blood pressure in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the diastolic blood pressure(mmHg) in PAR'}, {'measure': 'post-operative heart rate in post-anesthesia room (PAR)', 'timeFrame': '0 minutes', 'description': 'Record the heart rate (beat/min) in PAR'}, {'measure': 'post-operative heart rate in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the heart rate (beat/min) in PAR'}, {'measure': 'post-operative pulse oximeter in post-anesthesia room (PAR)', 'timeFrame': '0 minutes', 'description': 'Record the pulse oximeter(SpO2; %) in PAR'}, {'measure': 'postoperative pulse oximeter in post-anesthesia room (PAR)', 'timeFrame': '30 minutes', 'description': 'Record the pulse oximeter(SpO2; %) in PAR'}, {'measure': 'Numerical Rating Score (NRS) for pain score in ward', 'timeFrame': '1 hour after transferring to ward', 'description': 'Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'Numerical Rating Score (NRS) for pain score in ward', 'timeFrame': '2 hours after transferring to ward', 'description': 'Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'Numerical Rating Score (NRS) for pain score in ward', 'timeFrame': '4 hours after transferring to ward', 'description': 'Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'Numerical Rating Score (NRS) for pain score in ward', 'timeFrame': '8 hours after transferring to ward', 'description': 'Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'Numerical Rating Score (NRS) for pain score in ward', 'timeFrame': '24 hours after transferring to ward', 'description': 'Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)'}, {'measure': 'total analgesics requirement in ward', 'timeFrame': '24hr after transferring to ward', 'description': 'Record total analgesic requirement (mg) in ward'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid-induced hyperalgesia, remifentanil'], 'conditions': ['Opioid-Induced Disorders']}, 'descriptionModule': {'briefSummary': 'The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.', 'detailedDescription': '1. After obtaining informed consent, patients will be randomized into two groups.\n2. All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.\n3. group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube\n4. group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube\n5. In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting\n6. In ward: record the numerical rating scale (NRS) and total analgesics consumption'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'breast cancer female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)\\~III(A patient with severe systemic disease)\n* Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)\n\nExclusion Criteria:\n\n* Subject's ASA (American Society of Anesthesiologists) Physical Status Classification \\>3\n* Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery\n* Subject has psychiatric disease\n* allergic to opioid or propofol\n* History of alcoholism\n* History of drug abuse"}, 'identificationModule': {'nctId': 'NCT03812003', 'briefTitle': 'Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion', 'orgStudyIdInfo': {'id': '2-107-05-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'remifentanil', 'description': 'After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes.', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'NO_INTERVENTION', 'label': 'no intervention', 'description': 'After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes.'}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Remifentanil ALVOGEN powder'], 'description': 'remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml', 'armGroupLabels': ['remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wei-Hung Chan, Doctorate', 'role': 'CONTACT', 'email': 'whcken@gmail.com', 'phone': '886-2-87923311', 'phoneExt': '12546'}, {'name': 'Wei-Hung Chan, Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wei-Hung Chan, MD', 'role': 'CONTACT', 'email': 'whcken@gmail.com', 'phone': '886-2-78923311', 'phoneExt': '12546'}, {'name': 'Zhi-Fu Wu, MD', 'role': 'CONTACT', 'email': 'aneswu@gmail.com', 'phone': '886-2-78923311', 'phoneExt': '12852'}], 'overallOfficials': [{'name': 'Jyh-cherng Yu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Numerical rating scale, rescue analgesic amount'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wei-Hung Chan', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}