An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting

NCT06527703 | Completed DMC

• 1 other identifier: ThirstStudy
• Study Type: observational
• Target: 5,100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.

Conditions

Diabetes Mellitus; Hypertension; Ischaemic Heart Disease; Comorbidities and Coexisting Conditions; Fasting; Fasting, Time Restricted

Keywords

Preoperative fluid fasting time

Outcome Measures

Primary Outcomes (1)

• The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.

  Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.

  Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024

Study Arms (2)

preoperative liquid fasting duration in adult patients undergoing elective surgery

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded

Other: no intervention

preoperative liquid fasting time

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded

Other: no intervention

Interventions

no intervention OTHER

Patients have to answer a questionnaire. The following data will be recorded: Patient Number: Informed Consent: ☐ yes ☐ no Screening for eligibility Age \>/= 18 years: ☐ yes ☐ no Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Procedure: General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Type of Anaesthesia (choose 1): GA ☐ Sedation ☐ Regional ☐ Date and Time at which clear fluids were last consumed:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

preoperative liquid fasting duration in adult patients undergoing elective surgery; preoperative liquid fasting time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded

You may qualify if:

• Age ≥ 18 years
• Patients undergoing elective surgery
• Written informed consent

You may not qualify if:

• Age \< 18 years
• Urgent and emergency surgery

Sponsors & Collaborators

• Mater Dei Hospital, Malta: lead
• Puerta de Hierro University Hospital: collaborator

Study Sites (1)

Mater Dei Hospital

San Ġiljan, Msida, STJ 3711, Malta

Location

Related Publications (1)

• Camilleri Podesta AM, Sciberras S, Moisa E, Valletta L, Farrugia S, Paal P, Kouki P, Gasiunaite D, Vide S, Varosyan A, Golubovska I, Durnev V, Chkhaidze M, Kuci S, Vujovic B, Bilotta F. Preoperative liquid fasting practices in twelve European countries: A prospective multicentre cohort study (Thirst study). Eur J Anaesthesiol. 2026 Jan 8. doi: 10.1097/EJA.0000000000002347. Online ahead of print.

  PMID: 41504282 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Coronary Artery Disease; Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Feeding Behavior; Behavior

Study Officials

• Federico Bilotta, Prof

  PRINCIPAL INVESTIGATOR

• Anne Marie Camilleri Podesta, Dr

  Mater Dei Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)