Perioperative medicine & outcomes
Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial
Primary result · Global index of patient satisfactionResult — go to the resultMean difference −0.2 95% CI −1.9 to 1.6Authors' conclusion
A single low dose of oral midazolam premedication did not alter the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety.
Study context
- Population
- Patients aged 65 to 80 years scheduled for elective inpatient surgery ≥30 minutes under GA with planned extubation607 in primary analysis
- Participants
- 616 patients
- Comparison
- Midazolam vs Placebo
- Midazolamn = 309
- Placebon = 307reference
- Primary endpoint
- Global patient satisfaction (self-reported EVAN-G questionnaire)
- Follow-up
- First postoperative day
Methodological detailsdouble-blind, parallel-group, placebo-controlled, multicentre (9 German hospitals), Conducted October 2017 to May 2019 (last follow-up June 24, 2019)
- Double-blind
- Parallel-group
- Placebo-controlled
- Multicentre (9 German hospitals)
- Conducted October 2017 to May 2019 (last follow-up June 24, 2019)
Primary result
Global index of patient satisfaction
Mean difference
−0.2
95% CI −1.9 to 1.6
P = 0.85
By group
Midazolam
69.5
mean · SD 10.7
Placebo
69.6
mean · SD 10.8
Midazolam vs Placebo
mean difference −0.2 (95% CI −1.9 to 1.6); P = 0.85
As reported in the abstract
Secondary outcomes
Sensitivity (per-protocol, multiple imputation) and subgroup analyses (anxiety, frailty, sex, previous surgical experience)
- Did not alter the primary results
Other secondary outcomes (vital data, adverse events, serious complications, cognitive and functional recovery up to 30 days)
- Did not differ, except higher proportion with hypertension (SBP ≥160 mm Hg) at anesthesia induction in the placebo group
Original publication
Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial. JAMA Surg. Published 1 February 2024. doi:10.
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