Deep sedation for endoscopic cholangiopancreatography with or without pre or intraprocedural opioids: A double-blind randomised controlled trial.

摘要: BACKGROUND Propofol alone or combined with opioids is considered the drug of choice for sedation during endoscopic retrograde cholangiopancreatography (ERCP). OBJECTIVE To investigate effect pre intraprocedural on propofol requirement deep ERCP, and recovery, pain cognitive function postoperatively. DESIGN Three-arm, double-blinded randomised controlled trial. SETTING Aretaieio University Hospital, February 2011 to July 2013. PATIENTS One hundred eighty adults aged between 45 75 years. INTERVENTIONS Deep (target bispectral index 40 70) was performed. In remifentanil group (R), patients received intranasal placebo before 0.1 ml kg(-1) h(-1) (concentration 10 μg ml(-1)) ERCP. fentanyl (F), 200 ERCP (P), MAIN OUTCOME MEASURES The primary outcome total requirement. Secondary outcomes were recovery [assessed using Ramsay Sedation Scale score Observer's Assessment Alertness/Sedation Score (OAAS)] at 30 min; postoperative a visual analogue scale (VAS; 0 100 mm)]; MiniMental state test (max. 25 points) min after ERCP]. RESULTS Fifty-seven included in R, 59 F 57 P. requirements similar all groups (13 mg kg(-1); P = 0.97). scores OAAS (P 0.18 0.55, respectively). Postoperative median VAS differed among 0.007): F, five Cognitive high postprocedure (median 23 24) not different groups. CONCLUSION addition had no sedation, but who less minor pain. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01304342.