Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03529032
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2013-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-30', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of postoperative morphine consumption', 'timeFrame': 'first 48 hours postoperatively', 'description': 'Difference in milligrams of morphine used as rescue by patient controlled analgesia pump'}], 'secondaryOutcomes': [{'measure': 'Difference in pain scores, using the Numeric Rating Scale', 'timeFrame': 'first 72 hours postoperatively', 'description': 'Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['methadone', 'postoperative pain', 'acute pain therapy', 'postoperative pain therapy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.', 'detailedDescription': 'Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia.\n* german speaking patients\n\nExclusion Criteria:\n\n* patients including other studies\n* pregnant\n* breast feeding\n* patients in methadone substitution therapy\n* dependent drug user\n* patients with BMI greater than 36kg/m2\n* patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L\n* patients with liver insufficiency or failure\n* alcoholics\n* patients with acute heard attack'}, 'identificationModule': {'nctId': 'NCT03529032', 'briefTitle': 'Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baden'}, 'officialTitle': 'A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial', 'orgStudyIdInfo': {'id': 'Ref.Nr.EK:2011/052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Fentanyl group', 'description': 'Drug: Fentanyl Fentanyl group 3µg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60.'}, {'type': 'EXPERIMENTAL', 'label': 'methadone group', 'description': 'Drug: methadone methadone group 0.2mg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60.', 'interventionNames': ['Drug: Methadone']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'methadone for control postoperative pain', 'armGroupLabels': ['methadone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5404', 'city': 'Baden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}], 'overallOfficials': [{'name': 'Philipp Buehler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Baden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Philipp Bühler, MD', 'investigatorAffiliation': 'Kantonsspital Baden'}}}}