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Completed

NCT Number: NCT04769856

Impact of Non-fasting on Anxiety in Cataract Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Anesthésie Réanimation chirurgicale, Hôpital Cochin

Paris, IDF, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

State-Trait Anxiety Inventory (STAI) scale

Other

State-Trait Anxiety Inventory (STAI) scale

Satisfaction scale

Other

Satisfaction scale

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI) scale score

    Time frame: Baseline (Before surgery)

    preoperative anxiety level

Secondary outcomes

  1. Incidence of vitreous outbreaks perceived by the operator

    Time frame: During surgery

    Incidence of vitreous outbreaks perceived by the operator

  2. Incidence of capsular ruptures

    Time frame: During surgery

    Incidence of capsular ruptures

  3. Satisfaction scale score

    Time frame: Immediately after surgery

    Satisfaction scale score (scale from 0 to 10)

  4. Incidence of oxygen desaturations

    Time frame: During surgery

    Incidence of oxygen desaturations (SpO2 <93%)

  5. Proportion of patients who took their usual antihypertensive therapy

    Time frame: Baseline (Before surgery)

    Proportion of patients who took their usual antihypertensive therapy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: StarvAnx

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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