Midazolam sedation for upper gastrointestinal endoscopy in older persons: A randomized, double-blind, placebo-controlled study

OBJECTIVES: To investigate the benefits and risks of using midazolam for se dation during upper gastrointestinal endoscopic procedures in older persons . DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: A 304-bed geriatric university hospital. PATIENTS: Sixty-five geriatric inpatients (mean age 84 +/- 7) undergoing ga stroscopy. INTERVENTION: Sedation with either midazolam (30 mug/kg IV) or saline (plac ebo). All patients received supple mental oxygen during the procedure (2 L/ minute). MEASUREMENTS AND RESULTS: Patients' recall of their tolerance to the exam ( categorical scale) and pain score were significantly in favor of midazolam at 2 and 24 hours, Multivariate analysis at 2 hours showed that midazolam i ncreased the probability of good tolerance (odds ratio (OR) = 19.3; 95% con fidence interval (CI) 2.2-170.4, P = .008). Circumstantial amnesia occurred at 24 hours in 84% (midazolam) versus 27% (placebo) (P < .001). With midaz olam, mean sedation time was 83 +/- 13 minutes and mean arterial pressure ( MAP) was about 10 mm Hg lower without clinically significant hypotension. H ypoxemia (SaO(2) < 92%) was more frequent in the midazolam group after endo scopy (44% vs. 18%, P = .033), but no major desaturation was observed. Cogn itive function (Mini-Mental State Exam, MMSE) was similar before and 2 and 24 hours after the exam in both groups. Acute confusion was observed in two patients (1 midazolam, 1 placebo). Tn multivariate analysis, midazolam was associated with a higher risk of hypoxemia after endoscopy (OR = 3.5; 95% CI 1.1-10.8, P = .029) but not of confusion. CONCLUSIONS: Under adequate surveillance, the benefits in terms of toleranc e to the procedure of low-dose midazolam for upper gastrointestinal endosco pic sedation outweigh the risks in older people.