Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-20 @ 6:49 PM
Study NCT ID:
NCT02619032
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil and Fentanyl in Dental Surgery (REFEDS)
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': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D005283', 'term': 'Fentanyl'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline plasma cortisol values at 1 hour', 'timeFrame': 'At 1 hour after the induction of anesthesia and surgery', 'description': 'Plasma cortisol values were measured with an ELISA kit as mg/dl'}, {'measure': 'Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour', 'timeFrame': 'At 1 hour after the induction of anesthesia and surgery', 'description': 'Tumor necrosis factor-α (TNF-α) measurement was performed with Elisa immunoenzyme assay as pg/ml'}, {'measure': 'Change from baseline plasma substance-P values at 1 hour', 'timeFrame': 'At 1 hour after the induction of anesthesia and surgery', 'description': 'Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml'}, {'measure': 'Change from baseline plasma melatonin values at 1 hour', 'timeFrame': 'At 1 hour after the induction of anesthesia and surgery', 'description': 'Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml'}, {'measure': 'Change from baseline plasma β-endorphin values at 1 hour', 'timeFrame': 'At 1 hour after the induction of anesthesia and surgery', 'description': 'β-endorphin was measured with Elisa immunoenzyme assay as ng/ml'}], 'secondaryOutcomes': [{'measure': 'Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups', 'timeFrame': '1 hour', 'description': 'Measurements before the induction of anesthesia (baseline values) and at and 60 min (1 hour) after the induction of anesthesia'}, {'measure': 'Differences in intraoperative heart rate values (bmp) between the two study groups', 'timeFrame': '1 hour', 'description': 'Measurements before the induction of anesthesia (baseline values) and at 60 min (1 hour) after the induction of anesthesia'}, {'measure': 'Differences in postoperative pain scores scores between the two study groups', 'timeFrame': 'Up to 12 postoperative hours', 'description': 'Pain was assessed using the Wong-Baker faces pain rating scale (0-6) at 12 postoperative hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['remifentanil', 'fentanyl', 'dental surgery'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study was a prospective comparative study. The purpose of this study was to investigate the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary aims were to investigate comparatively their effect on patients intraoperative hemodynamic response and postoperative analgesia.', 'detailedDescription': "The study included 46 adult patients with cognitive impairment who underwent day-case dental surgery under general anesthesia with propofol aiming to keep a BIS-values range between 40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if needed.\n\nPatients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R, n=23). Randomization was performed using using a computer-generated randomization schedule.\n\nIntraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone 125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was administered to to reverse neuromuscular blockade. Intraoperative monitoring included non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry, capnography and Bispectral Sedation Index (BIS®).\n\nPostoperatively, patients remained under surveillance in the post-anesthesia care unit \\[PACU\\] for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min time-intervals for the first 3 hours, and every 3 hours thereafter by an independent observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.\n\nInflammation markers and stress hormones \\[cortisol, Tumor necrosis factor (TNF-a), substance-P, melatonin and β-endorphin\\] were measured in each patient before induction of anesthesia, after tracheal intubation and at the end of operation.\n\nStatistical Analysis was performed using Kolmogorov-Smirnov test, Student's unpaired t-test or Repeated Measures ANOVA with Holm's post-hoc analysis appropriately. A p value less than 0.05 was considered statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cognitive impairment\n* of category II according to the American Society of Anesthesiology (ASA) classification\n* scheduled for elective dental surgery with short duration\n\nExclusion Criteria:\n\n* Patients of more than category II of American Society of Anesthesiology (ASA) classification\n* Prolonged duration of surgery (\\>1 hour)'}, 'identificationModule': {'nctId': 'NCT02619032', 'acronym': 'REFEDS', 'briefTitle': 'Remifentanil and Fentanyl in Dental Surgery (REFEDS)', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Remifentanil vs Fentanyl During Day Case Dental Surgery in Persons With Special Needs: a Comparative Study of Their Effect on Stress Response and Postoperative Pain', 'orgStudyIdInfo': {'id': 'ATT968'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.', 'interventionNames': ['Drug: Remifentanil', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl', 'description': 'Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.', 'interventionNames': ['Drug: Remifentanil', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.', 'armGroupLabels': ['Fentanyl', 'Remifentanil']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['FNT'], 'description': 'Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.', 'armGroupLabels': ['Fentanyl', 'Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': '2nd Department of Anesthesiology, Attikon University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Eirini A Sklika, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asklepeion Voulas General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asklepieion Voulas General Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. of Anaesthesiology', 'investigatorFullName': 'Paraskevi Matsota', 'investigatorAffiliation': 'Attikon Hospital'}}}}