Propofol versus midazolam: safety and efficacy for sedating the severe trauma patient.
Previous studies have compared sedation profiles with midazolam (Mz) and propofol (Pf), particularly in heterogeneous populations of patients. Decreases in blood pressure and heart rate have been reported after the administration of propofol. These side effects are potentially deleterious in severe trauma patients, particularly in patients with head trauma. To assess the safety and efficacy of Mz and Pf, alone or in combination, in the prolonged sedation of severe trauma patients, we designed a prospective, controlled, randomized, study. One hundred consecutively admitted trauma patients requiring mechanical ventilation and sedation for more than 48 h were studied. Patients were sedated according to three different protocols based on the continuous i.v. administration of Mz alone, Pf alone, and Mz in combination with Pf. All patients received morphine chloride. Safety and efficacy were assessed during the sedation and wake-up periods according to clinical and laboratory variables. Cerebral hemodynamics were also studied in patients with head trauma. Patients were sedated for 6.3 +/- 4.0 days (mean +/- SD). All three sedation regimens were equally efficacious in achieving the desired sedation goal. The incidence of adverse events during the sedation period was also similar. In head trauma patients with intracranial pressure (ICP) monitoring, we did not find differences in ICP, cerebral perfusion pressure, or jugular venous oxygen saturation among the three groups. The serum triglyceride concentration was significantly higher in the Pf group. Wake-up time was significantly shorter in the Pf group. We conclude that both Mz and Pf are safe and efficacious in the sedation of severe trauma patients. The use of Pf in these patients is associated with a high incidence of hypertriglyceridemia and a shorter wake-up time.


CONCLUSIONS
In a prospective, controlled, randomized study, we confirmed the safety and efficacy of midazolam and propofol, alone or in combination, in the prolonged sedation of a homogeneous group of severe trauma patients, particularly in patients with head trauma. The propofol group had shorter wake-up times and higher triglyceride levels.
Sanchez-Izquierdo-Riera
J A
JA
Department of Intensive Care Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.
Caballero-Cubedo
R E
RE
Perez-Vela
J L
JL
Ambros-Checa
A
A
Cantalapiedra-Santiago
J A
JA
Alted-Lopez
E
E
D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000762:Anesthesia Recovery Period; D001794:Blood Pressure / Q000187:drug effects; D001921:Brain / Q000187:drug effects / Q000502:physiology; D006259:Craniocerebral Trauma / Q000628:therapy*; D004338:Drug Combinations; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007262:Infusions, Intravenous; D007427:Intracranial Pressure / Q000187:drug effects; D007601:Jugular Veins; D008297:Male; D008874:Midazolam / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D009020:Morphine / Q000627:therapeutic use; D010100:Oxygen / Q000097:blood; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012121:Respiration, Artificial; D012449:Safety; D014280:Triglycerides / Q000097:blood; D014947:Wounds and Injuries / Q000628:therapy*
D000701:Analgesics, Opioid; D004338:Drug Combinations; D006993:Hypnotics and Sedatives; D014280:Triglycerides; D009020:Morphine; D008874:Midazolam; D010100:Oxygen; D015742:Propofol