A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL OF SEDATION VS. NO SEDATION IN OUTPATIENT DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY

Background and Study Aims: The majority of gastrointestinal endoscopis ts in the United Kingdom routinely use intravenous sedation prior to d iagnostic upper gastrointestinal endoscopy, We conducted a prospective , randomized controlled clinical trial to help determine whether the u se of sedation influences the duration, safety, and tolerance of diagn ostic upper gastrointestinal endoscopy. Patients and Methods: Adults r eferred for outpatient diagnostic upper gastrointestinal endoscopy wer e invited to participate in the study, Patients with a history of prev ious upper gastrointestinal endoscopy or dysphagia were excluded, Pati ents were prospectively randomized to sedation with intravenous midazo lam (5 mg for those under 65 years or 3 mg for those aged 65 or more), or no sedation, All patients were given topical oropharyngeal anaesth esia with 100mg lignocaine spray, Outcome measures included duration o f procedure, ease of procedure (as assessed by medical and nursing sta ff), tolerance of procedure (as assessed by patients), and incidence o f complications. Results: 100 patients were randomized to receive seda tion or no sedation, The two groups were well matched for age, sex, an d number of biopsies taken during the procedure, In the non-sedated gr oup, the duration of endoscopy tended to be reduced and the procedure tended to be easier according to the endoscopists' assessment (neither of these observations was significant), The sedated group reported gr eater comfort for the procedure (P<0.001), although both groups tolera ted the procedure well, and the majority in both groups preferred to h ave any future procedure repeated in the same manner, There were no se rious adverse events in either group. Conclusions: In patients who are willing to contemplate upper gastrointestinal endoscopy without sedat ion, the avoidance of sedation may lead to faster and easier endoscopi es, without any increased risk of procedural difficulties or adverse e vents.