Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-05 @ 11:37 PM
Study NCT ID:
NCT04910659
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline sore throat at 24 h', 'timeFrame': 'baseline to 24 hours', 'description': 'postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.'}, {'measure': 'Change from Baseline postoperative cough at 24 hours', 'timeFrame': 'baseline to 24 hours', 'description': 'postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent'}, {'measure': 'Change from Baseline postoperative snoring at 24 hours', 'timeFrame': 'baseline to 24 hours', 'description': 'postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent'}], 'secondaryOutcomes': [{'measure': 'duration of operation', 'timeFrame': '24 hour'}, {'measure': 'resistance to Laringeal mask placement (none, mild, moderate, severe)', 'timeFrame': '24 hours', 'description': '1. none\n2. mild\n3. moderate\n4. severe'}, {'measure': 'time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation', 'timeFrame': '24 hours', 'description': 'time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sore Throat', 'Laryngeal Mask Airway', 'Acupuncture'], 'conditions': ['Acupuncture', 'Laryngeal Mask Airway', 'Pain, Postoperative', 'Sore Throat']}, 'descriptionModule': {'briefSummary': 'the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.', 'detailedDescription': 'Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.\n\nUsing the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who recieved general anesthesia with LMA\n* surgery duration \\< 2 hours\n* between 18-60 years of age\n* ASA1-2 scores\n\nExclusion Criteria:\n\n1. Being younger than 18 years old or being over the age of 60\n2. Patients with an ASA score of 3 and greater than 3\n3. Active infections in the area to be acupuncture.\n4. Prolonged bleeding time\n5. Liver failure\n6. Renal insufficiency\n7. Pregnancy\n8. Heart failure 9 . Patients less than 30 kg\n\n10\\. Uncontrolled hypertension\n\n11\\. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction\n\n12\\. Those who do not have the ability to read and sign the consent form\n\n13\\. Patients with gastroesophageal reflux\n\n14\\. History of any herbal medicine use\n\n15\\. Patients who do not want to sign the consent form\n\n16\\. Patients with difficult LMA placement\n\n17.Patients who cannot have LMA placement at one time\n\n18\\. Intubated patients in whom LMA could not be placed\n\n19 Patients whose operation time exceeds two hours\n\n20 .Patients whose operation time is less than 30 minutes'}, 'identificationModule': {'nctId': 'NCT04910659', 'briefTitle': 'Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask', 'orgStudyIdInfo': {'id': 'E1-19-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'acupuncture', 'description': 'Group1, laser acupuncture was applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds', 'interventionNames': ['Other: acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'false acupuncture', 'description': 'P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed', 'interventionNames': ['Other: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'description': 'P6, LI4 and LI 11 stimulation', 'armGroupLabels': ['acupuncture', 'false acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Feryal Akçay', 'role': 'CONTACT', 'phone': '+905459735654'}], 'facility': 'Ankara City Hospital Bilkent', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'FERYAL AKÇAY', 'role': 'CONTACT', 'email': 'feryalkakcay@gmail.com', 'phone': '+905459735654'}, {'name': 'TUNAHAN ÇEVİK', 'role': 'CONTACT', 'email': 'drtunahanceviknumune@gmail.com', 'phone': '+905459735654'}], 'overallOfficials': [{'name': 'FERYAL AKÇAY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'FERYAL AKÇAY', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}