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

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
State-Trait Anxiety Inventory (STAI) scale
Satisfaction scale
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract Surgery focused on measuring Cataract surgery, Anxiety, Fasting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service Anesthésie Réanimation chirurgicale, Hôpital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-fasting group

Fasting group

Arm Description

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory (STAI) scale score
preoperative anxiety level

Secondary Outcome Measures

Incidence of vitreous outbreaks perceived by the operator
Incidence of vitreous outbreaks perceived by the operator
Incidence of capsular ruptures
Incidence of capsular ruptures
Satisfaction scale score
Satisfaction scale score (scale from 0 to 10)
Incidence of oxygen desaturations
Incidence of oxygen desaturations (SpO2 <93%)
Proportion of patients who took their usual antihypertensive therapy
Proportion of patients who took their usual antihypertensive therapy

Full Information

First Posted
January 29, 2021
Last Updated
January 14, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04769856
Brief Title
Impact of Non-fasting on Anxiety in Cataract Surgery
Acronym
StarvAnx
Official Title
Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
Cataract surgery, Anxiety, Fasting

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-fasting group
Arm Type
Experimental
Arm Title
Fasting group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
State-Trait Anxiety Inventory (STAI) scale
Intervention Description
State-Trait Anxiety Inventory (STAI) scale
Intervention Type
Other
Intervention Name(s)
Satisfaction scale
Intervention Description
Satisfaction scale
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI) scale score
Description
preoperative anxiety level
Time Frame
Baseline (Before surgery)
Secondary Outcome Measure Information:
Title
Incidence of vitreous outbreaks perceived by the operator
Description
Incidence of vitreous outbreaks perceived by the operator
Time Frame
During surgery
Title
Incidence of capsular ruptures
Description
Incidence of capsular ruptures
Time Frame
During surgery
Title
Satisfaction scale score
Description
Satisfaction scale score (scale from 0 to 10)
Time Frame
Immediately after surgery
Title
Incidence of oxygen desaturations
Description
Incidence of oxygen desaturations (SpO2 <93%)
Time Frame
During surgery
Title
Proportion of patients who took their usual antihypertensive therapy
Description
Proportion of patients who took their usual antihypertensive therapy
Time Frame
Baseline (Before surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service Anesthésie Réanimation chirurgicale, Hôpital Cochin
City
Paris
State/Province
IDF
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28652955
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.
Results Reference
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PubMed Identifier
24384865
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.
Results Reference
background
PubMed Identifier
8343333
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.
Results Reference
background
PubMed Identifier
11437763
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.
Results Reference
background
PubMed Identifier
29863606
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.
Results Reference
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Impact of Non-fasting on Anxiety in Cataract Surgery

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