3323 Synergistic sedation with midazolam and propofol versus sedation with propofol alone for interventional endoscopic procedures. A doubleblind, randomized comparison.

Abstract

Adequate patient sedation is mandatory for most interventional endoscopic procedures. Recent anaesthesiologic studies indicates that propofol and midazolam act synergistically in combination and therefore may be superior to sedation with propofol alone regarding sedation efficacy, recovery and costs (due to presumed lower total dose of propofol needed). Methods: Two-hundred and thirty-nine consecutive patients undergoing therapeutic EGD or ERCP (EGD/ERCP-ratio, 1:1) randomly received either propofol alone (n=120, group A, loading dose 40-60 mg, followed by repeated doses of 20 mg) or midazolam plus propofol (n=119, group B, initial midazolam dose of 2.5-3.5 mg, followed by repeated doses of 20 mg of propofol) for sedation. Vital signs (heart rate, blood pressure, oxygen saturation, ecg) were continuously monitored and procedure-related parameters, the recovery time and quality (post-anaesthesia recovery score, PARS) as well as the patient`s co-operation and tolerance of the procedure (visual analogue scale) were prospectively assessed. Results: Patients of group A and B were well matched with respect to demographic and clinical data, endoscopic findings, and the performance of associated procedures. In group A a mean dose of 0.25 ± 0.13 mg/kg/min propofol was used whereas in group B only 0.20 ± 0.09 mg/kg/min of propofol (p < 0.01, plus additional 2.9 ± 0.5 mg of midazolam). Clinically relevant changes in vital signs were observed at comparable frequencies with a lowering of the systolic blood pressure < 90 mmHg in 6/119 patients of group B and 1/120 patients of group A (p=0.07). The sedation efficacy was rated nearly similar in both groups, whereas the mean recovery time (group A, 19 ± 7 min vs. group B, 25 ± 8 min, p< 0.05) as well as the recovery score (PARS group A, 8.0 ± 1.1 vs. PARS group B, 7.3 ± 1.2, p < 0.001) were significantly better in group A than in group B. Conclusion: During therapeutic endoscopy sedation with propofol and midazolam requires a lower total dose of propofol but otherwise has no superior sedation efficacy and is associated with a slower postprocedure recovery than sedation with propofol alone. Adequate patient sedation is mandatory for most interventional endoscopic procedures. Recent anaesthesiologic studies indicates that propofol and midazolam act synergistically in combination and therefore may be superior to sedation with propofol alone regarding sedation efficacy, recovery and costs (due to presumed lower total dose of propofol needed). Methods: Two-hundred and thirty-nine consecutive patients undergoing therapeutic EGD or ERCP (EGD/ERCP-ratio, 1:1) randomly received either propofol alone (n=120, group A, loading dose 40-60 mg, followed by repeated doses of 20 mg) or midazolam plus propofol (n=119, group B, initial midazolam dose of 2.5-3.5 mg, followed by repeated doses of 20 mg of propofol) for sedation. Vital signs (heart rate, blood pressure, oxygen saturation, ecg) were continuously monitored and procedure-related parameters, the recovery time and quality (post-anaesthesia recovery score, PARS) as well as the patient`s co-operation and tolerance of the procedure (visual analogue scale) were prospectively assessed. Results: Patients of group A and B were well matched with respect to demographic and clinical data, endoscopic findings, and the performance of associated procedures. In group A a mean dose of 0.25 ± 0.13 mg/kg/min propofol was used whereas in group B only 0.20 ± 0.09 mg/kg/min of propofol (p < 0.01, plus additional 2.9 ± 0.5 mg of midazolam). Clinically relevant changes in vital signs were observed at comparable frequencies with a lowering of the systolic blood pressure < 90 mmHg in 6/119 patients of group B and 1/120 patients of group A (p=0.07). The sedation efficacy was rated nearly similar in both groups, whereas the mean recovery time (group A, 19 ± 7 min vs. group B, 25 ± 8 min, p< 0.05) as well as the recovery score (PARS group A, 8.0 ± 1.1 vs. PARS group B, 7.3 ± 1.2, p < 0.001) were significantly better in group A than in group B. Conclusion: During therapeutic endoscopy sedation with propofol and midazolam requires a lower total dose of propofol but otherwise has no superior sedation efficacy and is associated with a slower postprocedure recovery than sedation with propofol alone.