Preoperative low-dose midazolam does not alter patient satisfaction of elderly undergoing surgery: JAMA

The randomized clinical trial (I-PROMOTE), including 616 adult patients scheduled for elective surgery with general anaesthesia showed that the mean global index of patient satisfaction on the first postoperative day evaluated by the Evaluation du Vécu de l’Anesthésie Generale questionnaire was 69.5 in the midazolam group and 69.6 in the placebo group, implying a nonsignificant difference.

Older patients are increasingly requiring surgery in the perioperative setting. Additionally, frailty, multimorbidity, and functional dependency are common in the elderly undergoing surgery. There is no clarity on the effect of oral midazolam premedication on patient satisfaction in the elderly undergoing surgery, despite its widespread use. Therefore, Ana Kowark, University Hospital Bonn, Bonn, Germany, and colleagues aimed to determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo.

I-PROMOTE, a parallel-group, double-blind, placebo-controlled RCT was conducted in nine German hospitals between 2017 and 2019. The trial enrolled patients aged 65 to 80 years who were scheduled for elective inpatient surgery for at least 30 minutes under general anaesthesia and with planned extubation.

616 patients were randomized to receive oral midazolam, 3.75 mg (n = 309), or placebo (n = 307) 30 to 45 minutes before anaesthesia induction. The primary outcome was global patient satisfaction assessed using the self-reported Evaluation du Vécu de l’Anesthésie Generale (EVAN-G) questionnaire on the first postoperative day. Key secondary outcomes were subgroup and sensitivity of the primary outcome, adverse events, perioperative patient vital data, serious complications, and functional and cognitive recovery up to 30 days postoperatively.

The study led to the following findings:

• Among 616 randomized patients, 607 were included in the primary analysis. Of these, 62.1% were male, and the mean age was 71.9 years.
• The mean global index of patient satisfaction did not differ between the midazolam and placebo groups (69.5 versus 69.6, respectively; mean difference, −0.2).
• Sensitivity (per-protocol population, multiple imputations) and subgroup analyses (frailty, anxiety, sex, and previous surgical experience) did not alter the primary results.
• Secondary outcomes did not differ, except for a higher proportion of patients with hypertension (systolic blood pressure ≥160 mm Hg) at anaesthesia induction in the placebo group.

The study showed that a singly low dose of oral midazolam premedication did not change the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety.

"These findings may be affected by the low dose of oral midazolam," the researchers wrote. "There is a need for further trials including a wider population with commonplace low-dose intravenous midazolam and plasma level measurements."

Reference:

Kowark A, Keszei AP, Schneider G, et al. Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial. JAMA Surg. Published online December 20, 2023. doi:10.1001/jamasurg.2023.6479