StarvAnx: Impact of Non-fasting on Anxiety in Cataract Surgery

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT04769856
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 20.8

Study Details

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	N/A

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
• 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: Nov 2, 2021
• Actual Study Completion Date: Nov 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 [Baseline (Before surgery)]

   preoperative anxiety level

Secondary Outcome Measures

1. Incidence of vitreous outbreaks perceived by the operator [During surgery]

   Incidence of vitreous outbreaks perceived by the operator

2. Incidence of capsular ruptures [During surgery]

   Incidence of capsular ruptures

3. Satisfaction scale score [Immediately after surgery]

   Satisfaction scale score (scale from 0 to 10)

4. Incidence of oxygen desaturations [During surgery]

   Incidence of oxygen desaturations (SpO2 <93%)

5. Proportion of patients who took their usual antihypertensive therapy [Baseline (Before surgery)]

   Proportion of patients who took their usual antihypertensive therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Service Anesthésie Réanimation chirurgicale, Hôpital Cochin	Paris	IDF	France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

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

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04769856
• Other Study ID Numbers: APHP201410
• First Posted: Feb 25, 2021
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 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

Study Results

No Results Posted as of Jan 18, 2022