Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-01 @ 10:43 AM
Study NCT ID:
NCT02041559
Status:
UNKNOWN
Last Update Posted:
2014-01-22
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-17', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney injury incidence based on Acute Kidney Injury Network criteria', 'timeFrame': '24 hours after end of surgery', 'description': 'Acute kidney injury incidence based on Acute Kidney Injury Network criteria was defined as increase in serum creatinine from baseline of ≥ 0.3 mg/dl within a 48-hour period. Acute kidney injury is evaluated at POD 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'male patients undergoing robot assisted prostatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages \\> 19 years and \\< 85 years\n* the patients undergoing a general anesthesia for robot assisted prostatectomy\n\nExclusion Criteria:\n\n* incomplete record\n* history of opioid or steroid using\n* solitary kidney\n* history of kidney transplantation'}, 'identificationModule': {'nctId': 'NCT02041559', 'briefTitle': 'The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0753'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'robot assisted prostatectomy', 'description': 'robot assisted prostatectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Eun Kim, MD', 'role': 'CONTACT', 'email': 'beye98@yuhs.ac', 'phone': '82-2-2019-6808'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ji Eun Kim, MD', 'role': 'CONTACT', 'email': 'beye98@yuhs.ac', 'phone': '82-2-2019-6808'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}