ArticleYonago acta medica2022
The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan.
Article in Yonago acta medica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01438931 (Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care
Who cites it
6 citing papers in PubMed, 10 citations in OpenAlex.
- Comparison Between Low-Dose Esketamine and Dexmedetomidine on Postoperative Recovery Quality Among Patients Undergoing Humeral Trauma Surgery in Interscalene Brachial Plexus Block: A Randomized, Double-Blind, Controlled Trial.Drug design, development and therapy · 2025Trial
- The Role of Dexmedetomidine in Burn Care: Sedation, Analgesia, and Beyond.Journal of burn care & research : official publication of the American Burn Association · 2026Review
- Dexmedetomidine Dosing Strategies in Sedation and Anesthesia: Pharmacokinetics, Safety, and Clinical Applications - A Narrative Review.Drug design, development and therapy · 2026Review
- Double-Blind, Randomized, Controlled Pilot Trial to Specify Collateral Effect and Safety of Perioperative Dexmedetomidine in Patients Undergoing Open Heart Surgery.Anesthesiology and pain medicine · 2025Article
- Exploring Ciprofol Alternatives: A Comprehensive Review of Intravenous Anesthesia Options.Cureus · 2024Review
- Evaluation of the Relationship between Baseline Autonomic Tone and Haemodynamic Effects of Dexmedetomidine.Pharmaceuticals (Basel, Switzerland) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFew studies (in other countries than the US) have reported on the efficacy and safety of dexmedetomidine for sedation of patients undergoing surgical or medical procedures under local anesthesia without intubation outside the intensive care unit. We performed a randomized, double-blind study in Japan.
methodsAdult patients were randomly allocated to receive placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min. Then, both dexmedetomidine groups received dexmedetomidine 0.2-0.7 μg/kg/h for maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients whose score exceeded this value. The primary endpoint was the percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of ≤ 4.
resultsIn total, 162 patients were included in the placebo (
conclusionWe concluded that a loading dose of 0.5 or 1.0 μg/kg dexmedetomidine followed by infusion at a rate of 0.2-0.7 μg/kg/h provided effective and well-tolerated sedation in patients undergoing surgical or medical procedures under local anesthesia without intubation. Clinical trials.gov identifier: NCT01438931.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.