Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-25 @ 2:51 PM
Study NCT ID:
NCT04314050
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the severity of CRBD', 'timeFrame': '0. hour', 'description': 'none - mild- moderate- severe'}, {'measure': 'the severity of CRBD', 'timeFrame': '1. hour', 'description': 'none - mild- moderate- severe'}, {'measure': 'the severity of CRBD', 'timeFrame': '3. hour', 'description': 'none - mild- moderate- severe'}, {'measure': 'the severity of CRBD', 'timeFrame': '6. hour', 'description': 'none - mild- moderate- severe'}], 'secondaryOutcomes': [{'measure': '11-point numerical rating scale (NRS)', 'timeFrame': '24 hours', 'description': "11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'tramadol', 'catheter-related bladder discomfort'], 'conditions': ['Catheter Related Complication']}, 'referencesModule': {'references': [{'pmid': '30603826', 'type': 'BACKGROUND', 'citation': 'Hur M, Park SK, Yoon HK, Yoo S, Lee HC, Kim WH, Kim JT, Ku JH, Bahk JH. Comparative effectiveness of interventions for managing postoperative catheter-related bladder discomfort: a systematic review and network meta-analysis. J Anesth. 2019 Apr;33(2):197-208. doi: 10.1007/s00540-018-2597-2. Epub 2019 Jan 2.'}, {'pmid': '18653496', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.'}, {'pmid': '25485879', 'type': 'BACKGROUND', 'citation': 'Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.'}, {'pmid': '26739975', 'type': 'BACKGROUND', 'citation': 'Akca B, Aydogan-Eren E, Canbay O, Karagoz AH, Uzumcugil F, Ankay-Yilbas A, Celebi N. Comparison of efficacy of prophylactic ketamine and dexmedetomidine on postoperative bladder catheter-related discomfort. Saudi Med J. 2016 Jan;37(1):55-9. doi: 10.15537/smj.2016.1.14122.'}, {'pmid': '30572837', 'type': 'RESULT', 'citation': 'Li S, Song L, Ma Y, Lin X. Tramadol for the treatment of catheter-related bladder discomfort: a randomized controlled trial. BMC Anesthesiol. 2018 Dec 20;18(1):194. doi: 10.1186/s12871-018-0659-5.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.', 'detailedDescription': 'Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD).\n\nThe incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD.\n\nTramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation.\n\nDexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%.\n\nThe first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 and 70 years\n* American Society of Anesthesiologists I or II\n* Scheduled to undergo retrograde intrarenal surgery\n* Scheduled to apply urinary catheter intraoperatively\n\nExclusion Criteria:\n\n* History of bladder outlet obstruction (Bening prostatic hypertrophy)\n* History of neurogenic bladder\n* History of psychiatric illness\n* Obese patient\n* Patients whose urinary catheter cannot be inserted\n* Patients who had previously urinary catheters'}, 'identificationModule': {'nctId': 'NCT04314050', 'briefTitle': 'Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery', 'orgStudyIdInfo': {'id': 'Urinery Catheter Discomfort'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tramadol', 'description': '1,5 mg /kg tramadol will perform intraoperatively in 100 ml saline within 15 minutes at 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.', 'interventionNames': ['Drug: Tramadol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': '1 mcg/kg dexmedetomidine bolus will perform after anesthesia induction and followed by infusion of 0.5 mcg/kg/h until 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '1 gr paracetamol will perform intraoperatively', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Tramadol', 'type': 'DRUG', 'otherNames': ['Contramal'], 'description': 'tramadol and paracetamol will perform', 'armGroupLabels': ['tramadol']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'dexmedetomidine and paracetamol will perform', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'control', 'type': 'OTHER', 'description': 'paracetamol will perform', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Fatma Özkan Sipahioglu, specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Diskapi Research and Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Department of Anesthesiology and Reanimation', 'investigatorFullName': 'Fatma Özkan Sipahioğlu', 'investigatorAffiliation': 'Ankara Diskapi Training and Research Hospital'}}}}