Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-05 @ 6:39 PM
Study NCT ID:
NCT04819659
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)', 'timeFrame': '10 minutes before extubation', 'description': 'measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.'}], 'secondaryOutcomes': [{'measure': 'Postoperative presence and severity of PONV', 'timeFrame': 'at the first, second and 24th hours in PACU and at the ward', 'description': 'The severity of PONV was assessed according to the four points score: None (0 point), nausea (1 point), nausea with maximum of two vomiting episodes (2 points), more than two vomiting episodes (3 points).\n\nWhen PONV with ≥ 2 points metaclopropamid 10 mg was done, and in order to repetition granisetron 3 mg was added.'}, {'measure': 'The severity of sore throat', 'timeFrame': 'at the first, second and 24th hours in PACU and at the ward', 'description': 'No pain (0 point), mild pain (1 point), moderate pain (2 points) and severe pain (3 points). Patients with severe sore throat were given paracetamol.'}, {'measure': 'Blood volume in the suction system', 'timeFrame': 'in the perioperative period', 'description': 'weighing sponge, pad, compress and blood volume in the aspirator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Nasal Surgery', 'Pharyngeal Packing', 'Gastric Volume', 'Postoperative Nausea']}, 'referencesModule': {'references': [{'pmid': '31286899', 'type': 'BACKGROUND', 'citation': 'Temel ME, Totoz T, Erkalp K, Temel GS, Selcan A. A randomized, double-blind study of the ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery. BMC Anesthesiol. 2019 Jul 8;19(1):121. doi: 10.1186/s12871-019-0786-7.'}, {'pmid': '12903007', 'type': 'BACKGROUND', 'citation': 'Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6.'}]}, 'descriptionModule': {'briefSummary': 'Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore, pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic. Actually, there is not any evidence in the literature reporting the quantitative values of gastric volumes due to blood ingestion. The aim of this study is to research the effect of pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the gastric volumes.\n\nMeasurements were performed by ultrasound with convex probe in right lateral decubitus position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing nasal surgery, and to show its effects on PONV and sore throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing elective nasal or paranasal sinus surgery following overnight fasting\n* 18-70 years of age\n* accepting to join the study\n* American Society of Anesthesiologist (ASA) classification system I-III\n* Body mass Index (BMI) \\< 30 kg/m2\n\nExclusion Criteria:\n\n* ASA classification higher than III\n* Age younger than 18 years\n* BMI\\>30 kg/m2\n* Preoperative vomiting or antiemetic medication therapy\n* Intubation needing more than two laryngoscopy attempts\n* Not agreeing to participate in the study\n* Coagulation disorders\n* Diseases or conditions affecting gastric volume or motility'}, 'identificationModule': {'nctId': 'NCT04819659', 'briefTitle': 'The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery', 'orgStudyIdInfo': {'id': '2020/1421'}, 'secondaryIdInfos': [{'id': 'E-29624016-050.99-411338', 'type': 'OTHER', 'domain': 'istanbul Faculty of Medicine Clin Res Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group Control', 'description': 'Without pharyngeal pack insertion'}, {'type': 'EXPERIMENTAL', 'label': 'Group Pharyngeal packing (Group PP)', 'description': 'Pharyngeal pack insertion after endotracheal intubation', 'interventionNames': ['Device: Pharyngeal packing']}], 'interventions': [{'name': 'Pharyngeal packing', 'type': 'DEVICE', 'description': 'Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.', 'armGroupLabels': ['Group Pharyngeal packing (Group PP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Department of Anesthesiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Demet Altun, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Demet Altun', 'investigatorAffiliation': 'Istanbul University'}}}}