Impact of Non-fasting on Anxiety in Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia

Conditions
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Cataract Surgery

Intervention / Treatment
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* Other: State-Trait Anxiety Inventory (STAI) scale
* Other: Satisfaction scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Information and collection of patient consent 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: Refusal to participate 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-fasting group<br> | Other: State-Trait Anxiety Inventory (STAI) scale<br>* State-Trait Anxiety Inventory (STAI) scale<br>Other: Satisfaction scale<br>* Satisfaction scale<br>|
| Experimental: Fasting group<br> | Other: State-Trait Anxiety Inventory (STAI) scale<br>* State-Trait Anxiety Inventory (STAI) scale<br>Other: Satisfaction scale<br>* Satisfaction scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) scale score | preoperative anxiety level | Baseline (Before surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vitreous outbreaks perceived by the operator | Incidence of vitreous outbreaks perceived by the operator | During surgery | 
| Incidence of capsular ruptures | Incidence of capsular ruptures | During surgery | 
| Satisfaction scale score | Satisfaction scale score (scale from 0 to 10) | Immediately after surgery | 
| Incidence of oxygen desaturations | Incidence of oxygen desaturations (SpO2 <93%) | During surgery | 
| Proportion of patients who took their usual antihypertensive therapy | Proportion of patients who took their usual antihypertensive therapy | Baseline (Before surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Anxiety, Fasting