OBJECTIVE:Midazolam sedation for upper gastrointestinal (GI) endoscopy exacerbates minimal hepatic encephalopathy (HE) in patients with liver cirrhosis, therefore an alternative drug regimen for these patients is warranted. The aim of this randomized, controlled study was to assess whether the use of the short-acting propofol as a sedative for GI endoscopy could prevent the exacerbation of minimal HE in patients with liver cirrhosis. MATERIAL AND METHODS: The study comprised patients with liver cirrhosis without clinical HE who had undergone upper GI endoscopy for therapeutic purposes (intended variceal band ligation). Sixty patients were randomly assigned into two groups to receive propofol (n=40) or midazolam (n=20) for upper GI endoscopy. The study groups were matched for age, gender and Child-Pugh score. All patients completed number connecting tests (NCTs), as well as a porto-systemic encephalopathy (PSE) syndrome test before and at 2 h after completion of the endoscopic procedure. Time needed to fulfill the tests was documented. Baseline results of the psychomotor test batteries were compared with the post-interventional evaluations. Data were also compared with the results of a healthy control group (n=20) that did not undergo endoscopic sedation. Recovery time and quality (score system) were evaluated. RESULTS: The differences in the NCT times before and after sedation (median delta NCT, midazolam group, 11 s (95% CI, -1.2 to 16.1 s) versus the propofol group, -9.5 s (95% CI, -15.7 to -4.6 s), p=0.002) and in the PSE scores (median delta PSE, midazolam group, -1 (95% CI, -1.5 to 0.2) versus the propofol group, 1 (95% CI, 0.5 to 1.5), p=0.0009) differed significantly between the two groups. In addition, the recovery time and quality in patients receiving propofol were significantly improved compared with in the midazolam group (7.8+/-2.9 min versus 18.4+/-6.7 min, 6.1+/-1.1 versus 8.2+/-1.3, both p<0.001). CONCLUSIONS: The study demonstrates that propofol sedation for upper GI endoscopy does not cause acute deterioration of minimal hepatic encephalopathy and is associated with improved recovery in patients with liver cirrhosis. Propofol should be recommended for these patients as an alternative to midazolam.
RCT Entities:
OBJECTIVE:Midazolam sedation for upper gastrointestinal (GI) endoscopy exacerbates minimal hepatic encephalopathy (HE) in patients with liver cirrhosis, therefore an alternative drug regimen for these patients is warranted. The aim of this randomized, controlled study was to assess whether the use of the short-acting propofol as a sedative for GI endoscopy could prevent the exacerbation of minimal HE in patients with liver cirrhosis. MATERIAL AND METHODS: The study comprised patients with liver cirrhosis without clinical HE who had undergone upper GI endoscopy for therapeutic purposes (intended variceal band ligation). Sixty patients were randomly assigned into two groups to receive propofol (n=40) or midazolam (n=20) for upper GI endoscopy. The study groups were matched for age, gender and Child-Pugh score. All patients completed number connecting tests (NCTs), as well as a porto-systemic encephalopathy (PSE) syndrome test before and at 2 h after completion of the endoscopic procedure. Time needed to fulfill the tests was documented. Baseline results of the psychomotor test batteries were compared with the post-interventional evaluations. Data were also compared with the results of a healthy control group (n=20) that did not undergo endoscopic sedation. Recovery time and quality (score system) were evaluated. RESULTS: The differences in the NCT times before and after sedation (median delta NCT, midazolam group, 11 s (95% CI, -1.2 to 16.1 s) versus the propofol group, -9.5 s (95% CI, -15.7 to -4.6 s), p=0.002) and in the PSE scores (median delta PSE, midazolam group, -1 (95% CI, -1.5 to 0.2) versus the propofol group, 1 (95% CI, 0.5 to 1.5), p=0.0009) differed significantly between the two groups. In addition, the recovery time and quality in patients receiving propofol were significantly improved compared with in the midazolam group (7.8+/-2.9 min versus 18.4+/-6.7 min, 6.1+/-1.1 versus 8.2+/-1.3, both p<0.001). CONCLUSIONS: The study demonstrates that propofol sedation for upper GI endoscopy does not cause acute deterioration of minimal hepatic encephalopathy and is associated with improved recovery in patients with liver cirrhosis. Propofol should be recommended for these patients as an alternative to midazolam.
Authors: John K Triantafillidis; Emmanuel Merikas; Dimitrios Nikolakis; Apostolos E Papalois Journal: World J Gastroenterol Date: 2013-01-28 Impact factor: 5.742