Upper gastrointestinal endoscopy: are preparatory interventions or conscious sedation effective? A randomized trial.

Aim: The fears and concerns are associated with gastroscopy (EGD) decrease patient compliance. Conscious sedation (CS) and non-pharmacological interventions have been proposed to reduce anxiety and allow better execution of EGD. The aim of this study was to assess whether CS, supplementary information with a videotape, or presence of a relative during the examination could improve the tolerance to EGD.

Methods: Two hundred and twenty-six outpatients (pts), scheduled for a first-time non-emergency EGD were randomly assigned to 4 groups: Co-group (62 pts): throat anaesthesia only; Mi-group (52 pts): CS with i.v. midazolam; Re-group (58 pts): presence of a relative throughout the procedure; Vi-group (54 pts): additional information with a videotape. Anxiety was measured using the "Spielberger State and Trait Anxiety Scales". The patients assessed the overall discomfort during the procedure on an 100-mm visual analogue scale, and their tolerance to EGD answering a questionnaire. The endoscopist evaluated the technical difficulty of the examination and the tolerance of the patients on an 100-mm visual analogue scale and answering a questionnaire.

Results: Pre-endoscopy anxiety levels were higher in the Mi-group than in the other groups (P<0.001). On the basis of the patients' evaluation, EGD was well tolerated by 80.7% of patients in Mi-group, 43.5% in Co-group, 58.6% in Re-group, and 50% in Vi-group (P<0.01). The discomfort caused by EGD, evaluated by either the endoscopist or the patients, was lower in Mi-group than in the other groups. The discomfort was correlated with "age" (P<0.001) and "groups of patients" (P<0.05) in the patients' evaluation, and with "gender" (females tolerated better than males, P<0.001) and "groups of patients" (P<0.05) in the endoscopist's evaluation.

Conclusion: Conscious sedation can improve the tolerance to EGD. Male gender and young age are predictive factors of bad tolerance to the procedure.