Clinical Trials Directory

Trials / Completed

CompletedNCT04769856

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
Phase
N/A
Study type
Interventional
Enrollment
126 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERState-Trait Anxiety Inventory (STAI) scaleState-Trait Anxiety Inventory (STAI) scale
OTHERSatisfaction scaleSatisfaction scale

Timeline

Start date
2021-05-02
Primary completion
2021-11-02
Completion
2021-11-02
First posted
2021-02-25
Last updated
2025-09-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04769856. Inclusion in this directory is not an endorsement.