Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT04769856
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Non-fasting on Anxiety in Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State-Trait Anxiety Inventory (STAI) scale score', 'timeFrame': 'Baseline (Before surgery)', 'description': 'preoperative anxiety level'}], 'secondaryOutcomes': [{'measure': 'Incidence of vitreous outbreaks perceived by the operator', 'timeFrame': 'During surgery', 'description': 'Incidence of vitreous outbreaks perceived by the operator'}, {'measure': 'Incidence of capsular ruptures', 'timeFrame': 'During surgery', 'description': 'Incidence of capsular ruptures'}, {'measure': 'Satisfaction scale score', 'timeFrame': 'Immediately after surgery', 'description': 'Satisfaction scale score (scale from 0 to 10)'}, {'measure': 'Incidence of oxygen desaturations', 'timeFrame': 'During surgery', 'description': 'Incidence of oxygen desaturations (SpO2 \\<93%)'}, {'measure': 'Proportion of patients who took their usual antihypertensive therapy', 'timeFrame': 'Baseline (Before surgery)', 'description': 'Proportion of patients who took their usual antihypertensive therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract surgery', 'Anxiety', 'Fasting'], 'conditions': ['Cataract Surgery']}, 'referencesModule': {'references': [{'pmid': '35911419', 'type': 'BACKGROUND', 'citation': 'Guerrier G, Bernabei F, Giannaccare G, Vagge A, Bonnet C, Baillard C, Monnet D, Rothschild PR. The StarvAnx Study-Comparison Between the Effects of Non-fasting Vs. Fasting Strategy on Surgical Outcomes, Anxiety and Pain in Patients Undergoing Cataract Surgery Under Topical Anesthesia: A Randomized, Crossover, Controlled Trial. Front Med (Lausanne). 2022 Jul 13;9:916225. doi: 10.3389/fmed.2022.916225. eCollection 2022.'}, {'pmid': '28652955', 'type': 'BACKGROUND', 'citation': 'Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.'}, {'pmid': '24384865', 'type': 'BACKGROUND', 'citation': 'Ogino Y, Kakeda T, Nakamura K, Saito S. Dehydration enhances pain-evoked activation in the human brain compared with rehydration. Anesth Analg. 2014 Jun;118(6):1317-25. doi: 10.1213/ANE.0b013e3182a9b028.'}, {'pmid': '8343333', 'type': 'BACKGROUND', 'citation': 'Maltby JR, Hamilton RC. Preoperative fasting guidelines for cataract surgery under regional anaesthesia. Br J Anaesth. 1993 Jul;71(1):167. doi: 10.1093/bja/71.1.167-a. No abstract available.'}, {'pmid': '11437763', 'type': 'BACKGROUND', 'citation': 'Steeds C, Mather SJ. Fasting regimens for regional ophthalmic anaesthesia. A survey of members of the British Ophthalmic Anaesthesia Society. Anaesthesia. 2001 Jul;56(7):638-42. doi: 10.1046/j.1365-2044.2001.02116.x.'}, {'pmid': '29863606', 'type': 'BACKGROUND', 'citation': 'Seet E, Kumar CM, Eke T, Joshi GP. Starving Patients Before Cataract Surgery Under Regional Anesthesia: Needed or Not? Anesth Analg. 2018 Dec;127(6):1448-1451. doi: 10.1213/ANE.0000000000003504. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.', 'detailedDescription': "Fear of aspiration makes anesthetists reluctant to challenge standard pre-operative fasting guidelines recommending stopping eating solids and drinking clear fluid 6 hours and 2 hours, respectively before anesthesia. However, hunger and thirst exacerbates patients' anxiety, adversely impacts the patient's comfort and satisfaction, and enhances pain response leading to additional need for analgesia.\n\nPatients undergoing non-invasive procedures requiring no or light sedation may benefit from non-fasting recommendations. The need for preoperative fasting in patients undergoing cataract surgery under topical anesthesia remains controversial. Patients are not fasted before standard cataract surgery under local anesthesia in many cataract centers, in accordance with the UK national guideline published in 2012. However, this practice is not supported by a high level of evidence from prospective clinical trials. So far, the lack of international professional consensus on the matter, local practices are based on institutional recommendations obviating the need for starvation in routine cataract surgery under topical anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Information and collection of patient consent\n* Age greater than or equal to 18 years\n* Affiliation to a social insurance\n* Undergoing cataract surgery under topical anesthesia\n* Intervention on the 1st eye\n\nExclusion Criteria:\n\n* Refusal to participate\n* Language barrier incompatible with the performance of a reliable assessment\n* Behavior disorders\n* Anesthesia other than topical\n* Voluntary control disorder\n* Intervention on the 2nd eye\n* Taking psychotropic drugs.\n* Legal protection regime'}, 'identificationModule': {'nctId': 'NCT04769856', 'acronym': 'StarvAnx', 'briefTitle': 'Impact of Non-fasting on Anxiety in Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia", 'orgStudyIdInfo': {'id': 'APHP201410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-fasting group', 'interventionNames': ['Other: State-Trait Anxiety Inventory (STAI) scale', 'Other: Satisfaction scale']}, {'type': 'EXPERIMENTAL', 'label': 'Fasting group', 'interventionNames': ['Other: State-Trait Anxiety Inventory (STAI) scale', 'Other: Satisfaction scale']}], 'interventions': [{'name': 'State-Trait Anxiety Inventory (STAI) scale', 'type': 'OTHER', 'description': 'State-Trait Anxiety Inventory (STAI) scale', 'armGroupLabels': ['Fasting group', 'Non-fasting group']}, {'name': 'Satisfaction scale', 'type': 'OTHER', 'description': 'Satisfaction scale', 'armGroupLabels': ['Fasting group', 'Non-fasting group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'IDF', 'country': 'France', 'facility': 'Service Anesthésie Réanimation chirurgicale, Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}