Clinical trial NCT04769856: Impact of Non-fasting on Anxiety in Cataract Surgery
Official title: Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Keywords: Cataract surgery
Anxiety
Fasting
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI) scale score
timeFrame: Baseline (Before surgery)
Secondary outcomes:
measure: Incidence of vitreous outbreaks perceived by the operator
timeFrame: During surgery
measure: Incidence of capsular ruptures
timeFrame: During surgery
measure: Satisfaction scale score
timeFrame: Immediately after surgery
measure: Incidence of oxygen desaturations
timeFrame: During surgery
measure: Proportion of patients who took their usual antihypertensive therapy
timeFrame: Baseline (Before surgery)
Other outcomes:
Locations:
city: Paris
country: France
facility: Service Anesthésie Réanimation chirurgicale, Hôpital Cochin
state: IDF
Study officials:
References:
citation: Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.
citation: Ogino Y, Kakeda T, Nakamura K, Saito S. Dehydration enhances pain-evoked activation in the human brain compared with rehydration. Anesth Analg. 2014 Jun;118(6):1317-25. doi: 10.1213/ANE.0b013e3182a9b028.
citation: Maltby JR, Hamilton RC. Preoperative fasting guidelines for cataract surgery under regional anaesthesia. Br J Anaesth. 1993 Jul;71(1):167. doi: 10.1093/bja/71.1.167-a. No abstract available.
citation: Steeds C, Mather SJ. Fasting regimens for regional ophthalmic anaesthesia. A survey of members of the British Ophthalmic Anaesthesia Society. Anaesthesia. 2001 Jul;56(7):638-42. doi: 10.1046/j.1365-2044.2001.02116.x.
citation: Seet E, Kumar CM, Eke T, Joshi GP. Starving Patients Before Cataract Surgery Under Regional Anesthesia: Needed or Not? Anesth Analg. 2018 Dec;127(6):1448-1451. doi: 10.1213/ANE.0000000000003504. No abstract available.