Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-30 @ 8:43 PM
Study NCT ID:
NCT03815435
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007023', 'term': 'Hypotension, Controlled'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study subjects will be enrolled into one arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2019-01-21', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical field clarity in relation to the value of arterial pressure', 'timeFrame': '13 months', 'description': "Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)"}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '13 months', 'description': 'Blood pressure will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.'}, {'measure': 'Heart rate', 'timeFrame': '13 months', 'description': 'Heart rate will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.'}, {'measure': 'Depth of anaesthesia', 'timeFrame': '13 months', 'description': 'Depth of anaesthesia will be measured using the BIS value every 5 minutes'}, {'measure': 'Near infrared spectroscopy (NIRS)', 'timeFrame': '13 months', 'description': 'Cerebral perfusion will be measured using the NIRS value every 5 minutes'}, {'measure': 'Consumption of hypotensives', 'timeFrame': '13 months', 'description': 'Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr'}, {'measure': 'Blood loss', 'timeFrame': '13 months', 'description': 'Blood loss (ml) during the surgery will be measured'}, {'measure': 'Recovery from anaesthesia duration', 'timeFrame': '13 months', 'description': 'The interval from the end of surgery to eye opening in minutes will be measured.'}, {'measure': 'Postoperative pain', 'timeFrame': '13 months', 'description': 'Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.'}, {'measure': 'Cognitive function', 'timeFrame': '13 months', 'description': 'The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.'}, {'measure': 'Postoperative nausea', 'timeFrame': '13 months', 'description': 'The presence of postoperative nausea (YES/NO) will be observed.'}, {'measure': 'Postoperative vomiting', 'timeFrame': '13 months', 'description': 'The presence of postoperative vomiting (YES/NO) will be observed.'}, {'measure': 'Complications of controlled hypotension', 'timeFrame': '13 months', 'description': 'The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.'}, {'measure': 'Use of tamponade', 'timeFrame': '13 months', 'description': 'The need to use tamponade due to bleeding (YES/NO) will be observed.'}, {'measure': 'Surgical revision', 'timeFrame': '13 months', 'description': 'The need for surgical revision due to bleeding (YES/NO) will be observed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical field clarity', 'Endonasal surgery', 'Intraoperative bleeding'], 'conditions': ['Chronic Rhinosinusitis (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '23844295', 'type': 'BACKGROUND', 'citation': 'Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.'}, {'pmid': '23258603', 'type': 'BACKGROUND', 'citation': 'Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.'}, {'pmid': '17989575', 'type': 'BACKGROUND', 'citation': 'Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.'}, {'pmid': '23263204', 'type': 'BACKGROUND', 'citation': 'Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.', 'detailedDescription': "The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.\n\nNull hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.\n\nThis study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.\n\nStudy type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic rhinosinusitis undergoing pansinusoperation\n* Age over 18 years\n* Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)\n* Concrete anaesthetist (Michal Parma, MD)\n\nExclusion Criteria:\n\n* Coagulopathy\n* Thrombocytopathies\n* Vascular wall disorders\n* Thrombophlebitis\n* Anticoagulation or anti-aggregation therapy\n* History of malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03815435', 'briefTitle': 'The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery', 'orgStudyIdInfo': {'id': 'KARIM-01-ENSURGERY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Controlled hypotension', 'description': 'Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).', 'interventionNames': ['Procedure: Controlled hypotension']}], 'interventions': [{'name': 'Controlled hypotension', 'type': 'PROCEDURE', 'description': 'Controlled hypotension will be administered according to the clarity of the surgical field.', 'armGroupLabels': ['Controlled hypotension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70852', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Ondřej Jor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}