Impact of Non-fasting on Anxiety in Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract Surgery
• Interventions: Other: State-Trait Anxiety Inventory (STAI) scale; Other: Satisfaction scale

• Registration Number: NCT04769856
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Start: 2021-05-02
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-fasting group	Satisfaction scale	-
Fasting group	State-Trait Anxiety Inventory (STAI) scale	-
Fasting group	Satisfaction scale	-
Non-fasting group	State-Trait Anxiety Inventory (STAI) scale	-

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) scale score	Baseline (Before surgery)	preoperative anxiety level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service Anesthésie Réanimation chirurgicale, Hôpital Cochin; 🇫🇷 Paris, IDF, France