Anxiety during gastroscopy and colonoscopy Mental and Behavioural Disorders
Conditions
Interventions
This is an open-label, single-centre, randomized, controlled trial conducted at Princess Grace Hospital, Monaco. Consecutive adult outpatients scheduled for diagnostic gastroscopy and colonoscopy will
Sponsors
Princess Grace Hospital Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults with ASA physical status I–III planned for combined diagnostic upper and lower GI endoscopy in ambulatory care
Exclusion criteria
Exclusion criteria: 1. Legal incapacity 2. Hospital stay >24 h 3. Psychiatric disorders 4. Alcohol or toxic substance use 5. Severe renal failure (creatinine clearance <30 mL·min?¹) 6. Pregnancy or breastfeeding 7. Significant hearing impairment precluding music exposure 8. Urgent procedures 9. Lack of social insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Propofol consumption rate (mg·kg?¹·min?¹), defined as total propofol administered divided by body weight and by the intervention length (minutes from induction to procedure end) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure duration (minutes), from induction to end of procedure 2. Total ambulatory pathway time (minutes), from induction to return to ambulatory unit 3. Anxiety level measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score at preanaesthesia consultation and on arrival in the ambulatory unit 4. Haemodynamic changes (systolic and diastolic blood pressures and pulse pressure) before vs after procedure 5. Adverse events (e.g., bronchospasm, laryngospasm) recorded during procedure 6. Number of propofol vials used per case for the procedure | — |
Countries
Monaco
Contacts
Public ContactGildas Rousseau
Outcome results
None listed