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Impact of Non-fasting on Anxiety in Cataract Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04769856
Acronym
StarvAnx
Enrollment
126
Registered
2021-02-25
Start date
2021-05-02
Completion date
2021-11-02
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Surgery

Keywords

Cataract surgery, Anxiety, Fasting

Brief summary

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

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.

Interventions

OTHERState-Trait Anxiety Inventory (STAI) scale

State-Trait Anxiety Inventory (STAI) scale

OTHERSatisfaction scale

Satisfaction scale

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State-Trait Anxiety Inventory (STAI) scale scoreBaseline (Before surgery)preoperative anxiety level

Secondary

MeasureTime frameDescription
Incidence of vitreous outbreaks perceived by the operatorDuring surgeryIncidence of vitreous outbreaks perceived by the operator
Incidence of capsular rupturesDuring surgeryIncidence of capsular ruptures
Satisfaction scale scoreImmediately after surgerySatisfaction scale score (scale from 0 to 10)
Incidence of oxygen desaturationsDuring surgeryIncidence of oxygen desaturations (SpO2 \<93%)
Proportion of patients who took their usual antihypertensive therapyBaseline (Before surgery)Proportion of patients who took their usual antihypertensive therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026