Impact of Non-fasting on Anxiety in Cataract Surgery (StarvAnx)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Cataract Surgery

Treatments: Other: Satisfaction scale; Other: State-Trait Anxiety Inventory (STAI) scale

Study type: Interventional

Funder types: Other

Identifiers

NCT04769856

APHP201410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Non-fasting group

Experimental group

Treatment:

Other: State-Trait Anxiety Inventory (STAI) scale

Other: Satisfaction scale

Fasting group

Experimental group

Treatment:

Other: State-Trait Anxiety Inventory (STAI) scale

Other: Satisfaction scale