OBJECTIVES:Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. Propofol is currently under evaluation as an alternative to the combination of midazolam and meperidine for sedation during endoscopic procedures. The purpose of this study was to compare nurse-administered propofol to midazolam and meperidine for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. METHODS:Twenty outpatients who had known chronic liver disease (Child-Pugh class A or B) and were undergoing variceal screening were randomized to receive propofol or midazolam plus meperidine for sedation. Administration of sedation was performed by a registered nurse and supervised by the endoscopist. Outcome measures studied were induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function. RESULTS: The mean dose of propofol and meperidine/midazolam administered was 203 mg (SD 43.7, range 150-280) and 71.3 mg (SD 17.7, range 50-100)/5.3 mg (SD 0.9, range 3.0-6.0), respectively. The mean time to achieve adequate sedation was 3.6 min (SD 1.2) for the propofol group in comparison to 7.3 min (SD 2.8) for the meperidine/midazolam group (p<0.05). Procedure times between the groups were similar: propofol, 3.9 min (SD 1.9); midazolam/meperidine, 2.7 min (SD 0.8) (p=0.11). The level of sedation achieved by the propofol group was greater (p=0.0001). Time to full recovery was faster in the propofol group: 34.9 min (SD 10.3) versus 51.6 min (SD 18.4) (p<0.05). The mean time to reach a maximal level of alertness on the Observer's Assessment of Alertness and Sedation Scale for the propofol group was 15 min (SD 3.6) versus 29 min (SD 10.5) (p=0.001). Although both groups recorded a high level of satisfaction, patients receiving propofol expressed greater overall mean satisfaction with the quality of their sedation at the time of discharge (p<0.05), and reported a return to baseline function sooner in the majority of cases. Propofol achieved comparable levels of efficacy and safety to meperidine/midazolam in our study group. Both were well tolerated with minimal complications. CONCLUSIONS:Propofol sedation administered by registered nurses in the setting of adequate patient monitoring is efficacious and well tolerated in patients with liver disease who are undergoing variceal screening by upper endoscopy. Patients were more satisfied with the quality of sedation, and return to baseline function was usually sooner compared to results achieved with midazolam/meperidine. Propofol offers advantages over meperidine/midazolam in cirrhotic patients.
RCT Entities:
OBJECTIVES: Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. Propofol is currently under evaluation as an alternative to the combination of midazolam and meperidine for sedation during endoscopic procedures. The purpose of this study was to compare nurse-administered propofol to midazolam and meperidine for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. METHODS: Twenty outpatients who had known chronic liver disease (Child-Pugh class A or B) and were undergoing variceal screening were randomized to receive propofol or midazolam plus meperidine for sedation. Administration of sedation was performed by a registered nurse and supervised by the endoscopist. Outcome measures studied were induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function. RESULTS: The mean dose of propofol and meperidine/midazolam administered was 203 mg (SD 43.7, range 150-280) and 71.3 mg (SD 17.7, range 50-100)/5.3 mg (SD 0.9, range 3.0-6.0), respectively. The mean time to achieve adequate sedation was 3.6 min (SD 1.2) for the propofol group in comparison to 7.3 min (SD 2.8) for the meperidine/midazolam group (p<0.05). Procedure times between the groups were similar: propofol, 3.9 min (SD 1.9); midazolam/meperidine, 2.7 min (SD 0.8) (p=0.11). The level of sedation achieved by the propofol group was greater (p=0.0001). Time to full recovery was faster in the propofol group: 34.9 min (SD 10.3) versus 51.6 min (SD 18.4) (p<0.05). The mean time to reach a maximal level of alertness on the Observer's Assessment of Alertness and Sedation Scale for the propofol group was 15 min (SD 3.6) versus 29 min (SD 10.5) (p=0.001). Although both groups recorded a high level of satisfaction, patients receiving propofol expressed greater overall mean satisfaction with the quality of their sedation at the time of discharge (p<0.05), and reported a return to baseline function sooner in the majority of cases. Propofol achieved comparable levels of efficacy and safety to meperidine/midazolam in our study group. Both were well tolerated with minimal complications. CONCLUSIONS:Propofol sedation administered by registered nurses in the setting of adequate patient monitoring is efficacious and well tolerated in patients with liver disease who are undergoing variceal screening by upper endoscopy. Patients were more satisfied with the quality of sedation, and return to baseline function was usually sooner compared to results achieved with midazolam/meperidine. Propofol offers advantages over meperidine/midazolam in cirrhotic patients.