Randomized double-blind trial of midazolam/placebo and midazolam/fentanyl for sedation and analgesia in lower-extremity angiography

AJR Am J Roentgenol. 1991 Jul;157(1):173-6. doi: 10.2214/ajr.157.1.2048514.


Safety and efficacy of two drug regimens used for sedation and analgesia during lower-extremity angiography were studied. Midazolam (loading dose 14.5 micrograms/kg; maintenance dose, 7.2 micrograms/kg) with or without fentanyl (loading dose, 0.725 micrograms/kg; maintenance dose, 0.362 micrograms/kg) was administered in a blind fashion as an IV bolus to 50 patients. Hemodynamic responses were monitored, and a standardized questionnaire was given to the patient before, immediately after, and 8-24 hr after the procedure. Physicians also were asked questions after the procedure. Heart rate and oxygen saturation were not significantly different before and 2 min after administration or between groups. A small but significant decrease in blood pressure occurred 2 min after the loading dose was given in both groups. Both drug regimens had statistically significant anxiolytic effects; however, anxiolytic effects were superior in the midazolam/fentanyl group (p less than .02). Patients rated the overall effectiveness of anesthesia with midazolam/fentanyl as superior (p less than .02). Analysis of physicians' judgments of the effectiveness of sedation and analgesia showed a statistically significant advantage for the midazolam/fentanyl group (p less than .01). We conclude that midazolam/fentanyl appears to be as safe as and more efficacious than midazolam alone for sedation and analgesia during lower-extremity angiography.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Angiography*
  • Conscious Sedation*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fentanyl* / administration & dosage
  • Hemodynamics / drug effects
  • Humans
  • Infusions, Intravenous
  • Leg / diagnostic imaging
  • Male
  • Midazolam* / administration & dosage
  • Middle Aged


  • Midazolam
  • Fentanyl