Impact of Non-fasting on Anxiety in Cataract Surgery

Cataract Surgery Clinical Trial

— StarvAnx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769856
• Other study ID #: APHP201410
• Status: Completed
• Phase: N/A
• Start date: May 2, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: January 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

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

Locations

Country	Name	City	State
France	Service Anesthésie Réanimation chirurgicale, Hôpital Cochin	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Maltby JR, Hamilton RC. Preoperative fasting guidelines for cataract surgery under regional anaesthesia. Br J Anaesth. 1993 Jul;71(1):167. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory (STAI) scale score	preoperative anxiety level	Baseline (Before surgery)
Secondary	Incidence of vitreous outbreaks perceived by the operator	Incidence of vitreous outbreaks perceived by the operator	During surgery
Secondary	Incidence of capsular ruptures	Incidence of capsular ruptures	During surgery
Secondary	Satisfaction scale score	Satisfaction scale score (scale from 0 to 10)	Immediately after surgery
Secondary	Incidence of oxygen desaturations	Incidence of oxygen desaturations (SpO2 <93%)	During surgery
Secondary	Proportion of patients who took their usual antihypertensive therapy	Proportion of patients who took their usual antihypertensive therapy	Baseline (Before surgery)