Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-20 @ 12:32 PM
Study NCT ID:
NCT03979469
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-11', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discharge times from the hospital', 'timeFrame': '4 hours', 'description': 'Comparison of the discharge times from the hospital between opioid free and opioid based anesthesia using Discharge criteria based on physiological scoring system, evaluating respiration, circulation, level of consciousness, postoperative pain, postoperative nausea and vomiting and surgical site. A score 12 or more allows patient to leave safely from the hospital.'}, {'measure': 'Severity of postoperative pain', 'timeFrame': '24 hours', 'description': 'Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using Visual Analogue Scale for children aged 7 years and more. We instruct the patient to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far left end indicates "no pain"(0) and the far right end indicates "worst pain ever."(10)'}, {'measure': 'Severity of postoperative pain', 'timeFrame': '24 hours', 'description': 'Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using the Face, Legs, Activity, Cry, Consolability scale or FLACC scale for children between the ages of 3 years and 7 years. The scale has five criteria, which are each assigned a score of 0, 1 or 2.The scale is scored in a range of 0-10 with 0 representing no pain.'}], 'secondaryOutcomes': [{'measure': 'Extubation time', 'timeFrame': '30 minutes', 'description': 'Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups'}, {'measure': 'Discharge time from PACU', 'timeFrame': '60 minutes', 'description': 'Comparison of discharge time from postanesthesia unit, time interval between arrival from operating room until leaving postanesthesia unit, between the two groups using Aldrete scale, score of 9 or greater allows patient to leave postanesthesia unit'}, {'measure': 'Cost effect', 'timeFrame': '24 hours', 'description': 'Comparison of hospitalization fees among the two groups'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Anesthesia in Postoperative Pain', 'Effect of Anesthesia in Extubation Time', 'Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit', 'Effect of Anesthesia in Postoperative Adverse Events', 'Effect of Anesthesia in Discharge Time From the Hospital']}, 'descriptionModule': {'briefSummary': 'The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children,\n* American Society Anesthesia I, II,\n* ambulatory surgery\n\nExclusion Criteria:\n\n* Allergy to anesthetic and analgesic drugs,\n* history of neuromuscular,\n* renal, neurological, hepatic disease,\n* craniofacial anomalies,\n* Obstructive Sleep Apnea,\n* obesity,\n* cardiopulmonary diseases'}, 'identificationModule': {'nctId': 'NCT03979469', 'briefTitle': 'Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children', 'organization': {'class': 'OTHER', 'fullName': 'Athens General Children\'s Hospital "Pan. & Aglaia Kyriakou"'}, 'officialTitle': 'Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia', 'orgStudyIdInfo': {'id': 'Opioid free anesthesia 7.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'opiod free general anesthesia', 'description': 'In group A opioid free anesthesia is administered. Anesthesia and analgesia were achieved with ketamine(1mg/kg, bolus), dexmedetomidine(1mcg/kg, over 10 minutes), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg). Anesthesia induction with ketamine(1mg/kg), propofol 1% 2-3mg/kg, rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.', 'interventionNames': ['Drug: Ketamine, dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'opioid based general anesthesia', 'description': 'In group B opioid based anesthesia is administered.Anesthesia and analgesia were achieved with remifentanil(0.3mcg/kg/minute), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg).Anesthesia induction with propofol 1% 2-3mg/kg,fentanyl(2mcg/kg), rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.', 'interventionNames': ['Drug: fentanyl, remifentanil']}], 'interventions': [{'name': 'Ketamine, dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively', 'armGroupLabels': ['opiod free general anesthesia']}, {'name': 'fentanyl, remifentanil', 'type': 'DRUG', 'description': 'Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively', 'armGroupLabels': ['opioid based general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11526', 'city': 'Athens', 'country': 'Greece', 'facility': 'Childrens Hospital P. and A. Kyriakou Anesthesiology Department', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Athens General Children\'s Hospital "Pan. & Aglaia Kyriakou"', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant of Anesthesiology Department', 'investigatorFullName': 'Adelais Tsiotou', 'investigatorAffiliation': 'Athens General Children\'s Hospital "Pan. & Aglaia Kyriakou"'}}}}