Sedation with propofol plus midazolam versus propofol alone for interventional endoscopic procedures: a prospective, randomized study.
OBJECTIVE
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 in terms of sedation efficacy, recovery and costs (due to a presumed lower total dose of propofol needed).


METHODS
A total of 239 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 intravenously, followed by repeated doses of 20 mg) or propofol plus midazolam (n=119, group B, initial midazolam dose of 2. 5-3.5 mg intravenously, followed by repeated doses of 20 mg of propofol) for sedation. Vital signs (heart rate, blood pressure, oxygen saturation, electrocardiogram) were continuously monitored. Procedure-related parameters, the recovery time and quality (post-anaesthesia recovery score) as well as the patient's co-operation and tolerance to 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 type of associated procedures. In group A, a mean dose of 0.25 +/- 0.13 mg.min/kg propofol was used compared to 0.20 +/- 0.09 mg.min/kg of propofol in group B (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 six out of 119 patients in group B and one out of 120 patients in group A (P=0.07). The sedation efficacy was rated similarly 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 (post-anaesthesia recovery score group A, 8.0 +/- 1.1 vs. post-anaesthesia recovery score group B, 7.3 +/- 1.2, P < 0.001) were significantly better with propofol alone than with propofol plus midazolam.


CONCLUSIONS
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 post-procedure recovery than sedation with propofol alone.
Seifert
H
H
Department of Internal Medicine II, J.W. Goethe-University Hospital, Frankfurt am Main, Germany.
Schmitt
T H
TH
Gültekin
T
T
Caspary
W F
WF
Wehrmann
T
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000762:Anesthesia Recovery Period; D002760:Cholangiopancreatography, Endoscopic Retrograde; D016292:Procedural Sedation; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D005773:Gastroscopy; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008874:Midazolam; D008875:Middle Aged; D010147:Pain Measurement; D015742:Propofol; D011446:Prospective Studies
D008874:Midazolam; D015742:Propofol