Perioperative medicine & outcomes
Dexmedetomidine Infusion Versus Placebo During Light or Deep Anesthesia on Postoperative Delirium in Older Patients Undergoing Major Noncardiac Surgery: A Pilot Randomized Factorial Trial
Authors' conclusion
The findings of this pilot study demonstrate the feasibility of assessing dexmedetomidine versus placebo during light versus deep anesthesia on POD among older patients undergoing major noncardiac surgery
Study context
- Population
- Patients aged 60 years or older undergoing major noncardiac surgery78 completed
- Participants
- 80 patients
- Comparison
- Dexmedetomidine infusion 0.5 μg/kg/h vs normal saline placebo during light (BIS target 55) vs deep (BIS target 40) anaesthesia
- Dexmedetomidine-deepn = 19
- Dexmedetomidine-lightn = 20
- Placebo-deepn = 19reference
- Placebo-lightn = 20
- Primary endpoint
- Feasibility (consent and dropout rate, timely enrollment, blinded drug administration throughout surgery, no inadvertent unmasking, BIS target achieved throughout >70% of surgery, twice-daily POD screening)
Methodological detailsfactorial, 2x2 (1:1:1:1), placebo-controlled, blinded, November 1, 2021 to June 30, 2022
- Factorial
- 2x2 (1:1:1:1)
- Placebo-controlled
- Blinded
- November 1, 2021 to June 30, 2022
Primary result
As reported in the abstract
Feasibility
- Consent rate
- 86%
- Dropout rate
- 2.5%
- Average recruitment per center per month
- 5 patients
- Received scheduled study drug infusion throughout surgery
- ≈99%
- Achieved BIS targets throughout >70% of surgery duration
- ≈81%
Further findings
| Outcome | Values | Between-group difference (95% CI) | |
|---|---|---|---|
| POD, dexmedetomidine vs placebo (factor) | Placebo 17.9% (95% CI 9%–32.7%) | −10% (−28% to 7%) | |
| POD, light vs deep anaesthesia (factor) | Deep anesthesia 18.4% (95% CI 9.2%–33.4%) | −11% (−28% to 6%) | |
| −40−20020Difference (linear scale) |
- Postoperative delirium (POD), dexmedetomidine vs placebo (factor): Placebo n = 39
- POD, light vs deep anaesthesia (factor): Deep anesthesia n = 38
POD incidence, overall
- POD, 10 of 78 patients
- 13% (95% CI 7%-22%)
Original publication
Dexmedetomidine Infusion Versus Placebo During Light or Deep Anesthesia on Postoperative Delirium in Older Patients Undergoing Major Noncardiac Surgery: A Pilot Randomized Factorial Trial. Anesth Analg. Published 24 October 2023. doi:10. 1213/ ane. 0000000000006686
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