Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2021-05-02
2021-11-02
Brief Summary
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Detailed Description
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Patients 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Non-fasting group
State-Trait Anxiety Inventory (STAI) scale
State-Trait Anxiety Inventory (STAI) scale
Satisfaction scale
Satisfaction scale
Fasting group
State-Trait Anxiety Inventory (STAI) scale
State-Trait Anxiety Inventory (STAI) scale
Satisfaction scale
Satisfaction scale
Interventions
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State-Trait Anxiety Inventory (STAI) scale
State-Trait Anxiety Inventory (STAI) scale
Satisfaction scale
Satisfaction scale
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years
* Affiliation to a social insurance
* Undergoing cataract surgery under topical anesthesia
* Intervention on the 1st eye
Exclusion Criteria
* Language barrier incompatible with the performance of a reliable assessment
* Behavior disorders
* Anesthesia other than topical
* Voluntary control disorder
* Intervention on the 2nd eye
* Taking psychotropic drugs.
* Legal protection regime
18 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Service Anesthésie Réanimation chirurgicale, Hôpital Cochin
Paris, IDF, France
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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APHP201410
Identifier Type: -
Identifier Source: org_study_id
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