Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04447105
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2020-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Postoperative Recovery Between TIVA and Inhalation Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000769', 'term': 'Anesthesia, Inhalation'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will receive general anesthesia, therefore they can not know their anesthetic method.\n\nPhysicians involved in this study will investigate the outcomes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective randomized single-blinded study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of recovery', 'timeFrame': 'at 24 hours, 48 hours, 72 hours postoperatively', 'description': 'Change in the QoR-15K score from 24 hours to 72 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'at 24 hours, 48 hours, 72 hours postoperatively', 'description': 'Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting/movement from 24 hours to 72 hours postoperatively'}, {'measure': 'Postoperative nausea and vomiting during the first 24 hours postoperatively', 'timeFrame': 'during the first 24 hours postoperatively', 'description': 'Incidence of postoperative nausea and vomiting (%)'}, {'measure': 'Postoperative nausea and vomiting during the 24-48 hours postoperatively', 'timeFrame': 'during the 24-48 hours postoperatively', 'description': 'Incidence of postoperative nausea and vomiting (%)'}, {'measure': 'Postoperative nausea and vomiting during the 48-72 hours postoperatively', 'timeFrame': 'during the 48-72 hours postoperatively', 'description': 'Incidence of postoperative nausea and vomiting (%)'}, {'measure': 'Total fentanyl consumption during the first 24 hours postoperatively', 'timeFrame': 'during the first 24 hours postoperatively', 'description': 'Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively'}, {'measure': 'Total fentanyl consumption during the 24-48 hours postoperatively', 'timeFrame': 'during the 24-48 hours postoperatively', 'description': 'Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively'}, {'measure': 'Total fentanyl consumption during the 48-72 hours postoperatively', 'timeFrame': 'during the 48-72 hours postoperatively', 'description': 'Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively'}, {'measure': 'Quality of life at early post-discharge', 'timeFrame': 'day before surgery and at 3 weeks after discharge', 'description': 'Change in the Quality of life measured using the EuroQoL 5-dimension 5-level scale (EQ-5D-5L) from baseline to early-postdischarge phase'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of recovery after surgery', 'anesthetic method'], 'conditions': ['Enhanced Recovery After Surgery']}, 'referencesModule': {'references': [{'pmid': '25500679', 'type': 'BACKGROUND', 'citation': 'Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.', 'detailedDescription': 'Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia\n* American Society of Anesthesiologists (ASA) physical classification I-II\n* Willingness and ability to sign an informed consent document\n\nExclusion Criteria:\n\n* Do not understand our study\n* American Society of Anesthesiologists (ASA) physical classification III or more\n* Allergies to anesthetic or analgesic medications\n* Chronic pain, chronic analgesic or antidepressant or anticonvulsant use\n* Medical or psychological disease that can affect the treatment response\n* Patients who receive mechanical ventilation more than 2 hours after surgery'}, 'identificationModule': {'nctId': 'NCT04447105', 'briefTitle': 'Comparison of Postoperative Recovery Between TIVA and Inhalation Agent', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)', 'orgStudyIdInfo': {'id': '2003-177-1113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIVA group', 'description': 'Patients receiving total intravenous anesthesia with propofol.', 'interventionNames': ['Drug: total intravenous anesthesia with propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Desflurane group', 'description': 'Patients receiving inhalation anesthesia with desflurane.', 'interventionNames': ['Drug: inhalation anesthesia with desflurane']}], 'interventions': [{'name': 'total intravenous anesthesia with propofol', 'type': 'DRUG', 'otherNames': ['TIVA group'], 'description': 'In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.', 'armGroupLabels': ['TIVA group']}, {'name': 'inhalation anesthesia with desflurane', 'type': 'DRUG', 'otherNames': ['DES group'], 'description': 'In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.', 'armGroupLabels': ['Desflurane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KS013', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hojin Lee, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}