A prospective, randomized controlled trial of sedation vs. no sedation in outpatient diagnostic upper gastrointestinal endoscopy.

摘要

BACKGROUND AND STUDY AIMS: The majority of gastrointestinal endoscopists in the United Kingdom routinely use intravenous sedation prior to diagnostic upper gastrointestinal endoscopy. We conducted a prospective, randomized controlled clinical trial to help determine whether the use of sedation influences the duration, safety, and tolerance of diagnostic upper gastrointestinal endoscopy. PATIENTS AND METHODS: Adults referred for outpatient diagnostic upper gastrointestinal endoscopy were invited to participate in the study. Patients with a history of previous upper gastrointestinal endoscopy or dysphagia were excluded. Patients were prospectively randomized to sedation with intravenous midazolam (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 anaesthesia with 100 mg lignocaine spray. Outcome measures included duration of procedure, ease of procedure (as assessed by medical and nursing staff), tolerance of procedure (as assessed by patients), and incidence of complications. RESULTS: 100 patients were randomized to receive sedation or no sedation. The two groups were well matched for age, sex, and number of biopsies taken during the procedure. In the non-sedated group, 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 greater comfort for the procedure (P < 0.001), although both groups tolerated the procedure well, and the majority in both groups preferred to have any future procedure repeated in the same manner. There were no serious adverse events in either group. CONCLUSIONS: In patients who are willing to contemplate upper gastrointestinal endoscopy without sedation, the avoidance of sedation may lead to faster and easier endoscopies, without any increased risk of procedural difficulties or adverse events.