Evidence map›Paper›PMID 39986981›Full record

Trial reportBritish journal of anaesthesia2025

Effect of midazolam co-administered with oxycodone on ventilation: a randomised clinical trial in healthy volunteers.

Victoria Gershuny, Jeffry Florian, Rutger van der Schrier, Michael C Davis, Pablo Salcedo, Celine Wang, Keith Burkhart, Kristin Prentice, Aanchal Shah, Rebecca Racz and 10 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of anaesthesia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04310579 (Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04310579 phase1completednot on this map

Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation

TypeinterventionalSponsorFood and Drug Administration (FDA)Ran2020 to 2021Enrolled55ConditionsHypercapnia, Ventilatory DepressionArmsOxycodone and Midazolam, Oxycodone, Paroxetine, and Quetiapine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Effects of TPA023B, an α2/3/5GABAPsychopharmacology · 2026
    Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Victoria GershunyDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jeffry FlorianDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Rutger van der SchrierDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
Michael C DavisDivision of Psychiatry, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Pablo SalcedoDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Celine WangDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Keith BurkhartDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kristin PrenticeDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Booz Allen Hamilton, McLean, VA, USA.
Aanchal ShahDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Booz Allen Hamilton, McLean, VA, USA.
Rebecca RaczDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Vikram PatelDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Murali MattaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Omnia IsmaielDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Rodney BoughnerKCAS Bioanalytical Services, Shawnee, KS, USA.
Kevin A FordDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Rodney RouseDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Marc StoneDivision of Psychiatry, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Carlos SanabriaSpaulding Clinical Research, West Bend, WI, USA.
Albert DahanDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
David G StraussDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Jeffry.Florian@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBenzodiazepines can exacerbate opioid-induced respiratory depression by furthering the decrease in central respiratory drive and causing loss of upper airway patency potentially leading to airway obstruction. This study aimed to determine if co-administration of benzodiazepines and opioids significantly decreases hypercapnic ventilation compared with opioids alone.

methodsWe conducted a randomised, double-blind, four-period crossover trial in 20 healthy participants to assess whether i.v. midazolam (0.0375 mg kg

resultsMidazolam administered with oxycodone, compared with oxycodone alone, did not significantly decrease minute ventilation at an end-tidal Pco

conclusionsMidazolam co-administered with oxycodone did not decrease hypercapnic ventilation, compared with oxycodone alone, but did affect tidal volume, ventilatory frequency, and resting end-tidal Pco CLINICAL

trial registrationNCT04310579.

Indexed as

Analgesics, OpioidHypnotics and SedativesMidazolamOxycodoneRespirationAdultCarbon DioxideCross-Over StudiesDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultAnalgesics, OpioidCarbon DioxideHypnotics and SedativesMidazolamOxycodonebenzodiazepinesbreathingopioidspharmacodynamicspharmacokineticsrespiratory depression

Identifiers

PMID39986981
PMCPMC11947576

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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.