It may be time to rethink the widespread practice of routinely giving a sedative before anesthesia to patients undergoing elective surgery, suggest findings of the randomized multicenter PremedX trial.
Results published in the March 3 issue of JAMA show that compared with no premedication or a placebo, lorazepam premedication failed to improve patients’ overall satisfaction with the perioperative experience, the trial’s primary endpoint, and prolonged recovery.
“The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia,” the investigators write.
“Because a minority of patients have high degrees of anxiety, there is little justification for routine administration of preoperative anxiolytic medication for all surgical patients.”
Axel Maurice-Szamburski, MD, from the Service d’Anesth&eacte;sie Réanimation, Hôpital de la Timone Adulte, Marseille, France, and coinvestigators enrolled 1062 patients younger than 70 years scheduled for elective inpatient surgeries (excluding neurosurgery, obstetric, and cardiac cases) under general anesthesia at five French teaching hospitals. The researchers assigned patients to receive 2.5 mg lorazepam premedication, no premedication, or a placebo.
The main findings indicate that patient satisfaction with the perioperative experience, assessed the day after surgery with the Evaluation du Vécu de l’Anesthésie Generale questionnaire, did not differ significantly across groups. Scores on the 100-point global index averaged 72 (95% confidence interval [CI], 70 – 73) with lorazepam, 73 (95% CI, 71 – 74) with no premedication, and 71 (95% CI, 70 – 73) with placebo, with higher scores indicating greater satisfaction.
Findings were similar when analyses were restricted to the quarter of patients who had high levels of anxiety preoperatively.
In contrast, the time to extubation was longer in the lorazepam group (17 minutes; 95% CI, 14 – 20 minutes) than in the no-premedication group (12 minutes; 95% CI, 11 – 13 minutes) and the placebo group (13 minutes; 95% CI, 12 – 14 minutes). In addition, the proportion of patients with early cognitive recovery, assessed 40 minutes after the end of anesthesia with the Postoperative Quality of Recovery Scale, was lower with lorazepam (51%; 95% CI, 45% – 56%) than with no premedication (71%; 95% CI, 66% – 76%) or placebo (64%; 95% CI, 59% – 69%).
In additional findings, compared with peers in the placebo group, patients in the lorazepam group had lower levels of anxiety on arrival in and lower levels of pain on departure from the operating room. Amnesia during the perioperative period was more common with lorazepam (24% of patients) than with no premedication (6%) or placebo (6%), and the lorazepam group had less of an improvement in sleep quality between baseline and postoperative day 1 than either other group.
There were no significant differences with respect to the rate of hypotension after anesthetic induction or the rates of nausea, vomiting, hypothermia, shivering, or sore throat assessed in the postanesthesia care unit.
“Compared with placebo, lorazepam did reduce patient anxiety upon arrival to the operating room,” the investigators note. “Because there was no overall benefit from preoperative anxiety treatment, it is possible that anxiety arising upon arrival to the operating room does not influence overall patient satisfaction.”
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