Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04769856
Other study ID # APHP201410
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT02573610 - Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery Phase 3
Completed NCT02910362 - Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines N/A
Recruiting NCT01193504 - Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification Phase 4
Completed NCT01199510 - Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery Phase 4
Completed NCT01455233 - 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery Phase 4
Completed NCT04146961 - The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Completed NCT00585975 - Efficacy and Safety of Bromfenac Ophthalmic Solution Phase 2
Completed NCT00406913 - Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery N/A
Not yet recruiting NCT04131335 - Use of Prophylactic Lubricating Drops After Cataract Surgery N/A
Recruiting NCT05331690 - Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN) Phase 4
Withdrawn NCT04563559 - PREFERENTIAL Study Phase 2/Phase 3
Completed NCT04732351 - Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
Completed NCT02128113 - RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD Phase 2
Completed NCT03873454 - The Effects of Music on Perioperative Outcomes in Cataract Surgery N/A
Withdrawn NCT00604305 - Comperative Trial Between an Accommodative Iol and Monofocal Iol N/A
Completed NCT05925894 - Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. N/A
Not yet recruiting NCT06136780 - Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras N/A
Completed NCT04633954 - Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery N/A
Completed NCT03644875 - Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
Recruiting NCT04781231 - Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia N/A