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

• ClinicalTrials.gov Identifier: NCT04769856
• Recruitment Status: Completed
• First Posted: February 25, 2021
• Last Update Posted: January 18, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract Surgery	Other: State-Trait Anxiety Inventory (STAI) scale; Other: Satisfaction scale	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia
• Actual Study Start Date: May 2, 2021
• Actual Primary Completion Date: November 2, 2021
• Actual Study Completion Date: November 2, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Non-fasting group	Other: State-Trait Anxiety Inventory (STAI) scale; State-Trait Anxiety Inventory (STAI) scale; Other: Satisfaction scale; Satisfaction scale
Experimental: Fasting group	Other: State-Trait Anxiety Inventory (STAI) scale; State-Trait Anxiety Inventory (STAI) scale; Other: Satisfaction scale; Satisfaction scale

Outcome Measures

Primary Outcome Measures :

1. State-Trait Anxiety Inventory (STAI) scale score [ Time Frame: Baseline (Before surgery) ]
   preoperative anxiety level

Secondary Outcome Measures :

1. Incidence of vitreous outbreaks perceived by the operator [ Time Frame: During surgery ]
   Incidence of vitreous outbreaks perceived by the operator
2. Incidence of capsular ruptures [ Time Frame: During surgery ]
   Incidence of capsular ruptures
3. Satisfaction scale score [ Time Frame: Immediately after surgery ]
   Satisfaction scale score (scale from 0 to 10)
4. Incidence of oxygen desaturations [ Time Frame: During surgery ]
   Incidence of oxygen desaturations (SpO2 <93%)
5. Proportion of patients who took their usual antihypertensive therapy [ Time Frame: Baseline (Before surgery) ]
   Proportion of patients who took their usual antihypertensive therapy

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Service Anesthésie Réanimation chirurgicale, Hôpital Cochin

Paris, IDF, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

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.

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

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.

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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04769856
• Other Study ID Numbers: APHP201410
• First Posted: February 25, 2021
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Cataract surgery; Anxiety; Fasting

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases