CClinicalTrials.gg
Not yet recruitingNCT07734350Updated Jul 29, 2026

Cost-Effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Adults

An observational study in Critical Illness, Mechanical Ventilation and Respiratory Insufficiency, sponsored by Hospital H+ Queretaro. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Hospital H+ Queretaro · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to learn whether inhaled sedation is a cost-effective alternative to intravenous propofol in mechanically ventilated critically ill adults admitted to the intensive care unit. The main questions it aims to answer are:

  • Does inhaled sedation reduce the total cost of care compared with intravenous propofol?
  • Does inhaled sedation reduce the duration of mechanical ventilation and ICU length of stay?
  • Are adverse events different between patients receiving inhaled sedation and those receiving intravenous propofol?

Researchers will compare patients who received inhaled sedation with patients who received intravenous propofol to see if inhaled sedation improves clinical outcomes and reduces overall costs.

Participants will:

  • Be identified through review of electronic medical records
  • Be included if they are adults who received mechanical ventilation and were sedated with inhaled sedation or intravenous propofol
  • Contribute data on total costs of care, duration of mechanical ventilation, ICU length of stay, and adverse event
Read the detailed description

Sedation is an essential component of care for critically ill patients receiving invasive mechanical ventilation in the intensive care unit (ICU). It helps improve patient comfort, reduce metabolic demand, and facilitate ventilator synchrony. Intravenous propofol is widely used for this purpose because of its rapid onset and titratability, but it may be associated with adverse effects such as hypotension, hyperlipidemia, and propofol infusion syndrome. Inhaled sedation with volatile anesthetic agents has re-emerged as an alternative approach in ICU patients, with potential advantages including lower drug accumulation, rapid pulmonary elimination, and possibly shorter duration of mechanical ventilation and ICU stay.

This study is a retrospective observational cohort study conducted in the ICU of Hospital H+ Querétaro. It will include adult patients who required at least 24 hours of mechanical ventilation and received either inhaled sedation or continuous intravenous propofol sedation during their ICU stay. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.

The primary objective is to compare the total cost of inhaled sedation versus intravenous propofol in mechanically ventilated critically ill patients. Secondary objectives are to compare duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs between the two sedation strategies. The primary outcome is total cost of care, while secondary outcomes include days on mechanical ventilation, ICU stay, and adverse events. Additional variables such as age, sex, SOFA score, APACHE II score, and comorbidities will also be collected.

Data will be collected through review of electronic medical records and recorded in a standardized format. Statistical analysis will be performed using STATA. Descriptive statistics will summarize baseline characteristics and outcomes, and inferential analyses will be used to compare groups, with adjustment for relevant covariates when appropriate. The aim of the study is to determine whether inhaled sedation may represent a cost-effective strategy that improves resource use and clinical outcomes in the ICU setting.

02

Conditions studied

  • Critical Illness
  • Mechanical Ventilation
  • Respiratory Insufficiency

Keywords

  • Inhaled sedation
  • Propofol
  • Mechanical ventilation
  • Critical illness
  • Intensive care unit
  • Cost-effectiveness
  • Critical care sedation
  • Adult ICU patients
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received either inhaled sedation with isoflurane or continuous intravenous propofol sedation during ICU stay will be selected through retrospective review of electronic medical records

Inclusion criteria

  • Adults aged 18 years or older
  • Admission to the intensive care unit at Hospital H+ Querétaro
  • Invasive mechanical ventilation for at least 24 hours
  • Receipt of inhaled sedation or continuous intravenous propofol sedation during ICU stay

Exclusion criteria

Exclusion Criteria:

  • Extracorporeal membrane oxygenation
  • Severe traumatic brain injury
  • Transfer to another hospital unit
  • Less than 24 hours of mechanical ventilation
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Inhaled Sedation Cohort

    This cohort includes adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received inhaled sedation as their primary sedation strategy during ICU stay. In the study protocol, inhaled sedation is defined as the use of isoflurane administered through an anesthetic-conserving device. Patients in this cohort will be identified retrospectively through electronic medical record review and will be evaluated for total cost of care, duration of mechanical ventilation, ICU length of stay, adverse events, and relevant clinical covariates including age, sex, SOFA score, APACHE II score, and comorbidities. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.

    Drug: Isoflurane

  • Intravenous Propofol Cohort

    This cohort includes adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received continuous intravenous propofol as their primary sedation strategy during ICU stay. These patients will also be identified retrospectively through review of electronic medical records and will serve as the comparison group for the cost-effectiveness analysis. Outcomes assessed in this cohort will include total cost of care, duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs, as well as baseline and clinical covariates such as age, sex, SOFA score, APACHE II score, and comorbidities. The same exclusion criteria will be applied to maintain comparability between cohorts.

    Drug: Propofol (Astra-Zeneca)

Interventions

  • DrugIsoflurane

    Isoflurane administered as inhaled sedation through an anesthetic-conserving device in mechanically ventilated critically ill adult patients in the intensive care unit.

  • DrugPropofol (Astra-Zeneca)

    Propofol administered as continuous intravenous sedation in mechanically ventilated critically ill adult patients in the intensive care unit.

05

What researchers measure

Primary outcomes

  1. Total Cost of Care

    Time frame: Through ICU discharge, an average of 7 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Ramos FJDS, Santos MHCD, Pastore L Junior. Sedation with volatile anesthetics in the intensive care unit: a new option with old agents. Crit Care Sci. 2023 Mar 1;35(1):100-101. doi: 10.5935/2965-2774.20230394-en. No abstract available. PubMed 37712735 ↗
  • Fudickar A, Bein B. Propofol infusion syndrome: update of clinical manifestation and pathophysiology. Minerva Anestesiol. 2009 May;75(5):339-44. PubMed 19412155 ↗
  • Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29. PubMed 21445642 ↗
  • Jerath A, Parotto M, Wasowicz M, Ferguson ND. Volatile Anesthetics. Is a New Player Emerging in Critical Care Sedation? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1202-12. doi: 10.1164/rccm.201512-2435CP. PubMed 27002466 ↗
  • Al Aseri Z, Alansari MA, Al-Shami SA, Alaskar B, Aljumaiah D, Elhazmi A. The advantages of inhalational sedation using an anesthetic-conserving device versus intravenous sedatives in an intensive care unit setting: A systematic review. Ann Thorac Med. 2023 Oct-Dec;18(4):182-189. doi: 10.4103/atm.atm_89_23. Epub 2023 Oct 17. PubMed 38058786 ↗
  • Jabaudon M, Zhai R, Blondonnet R, Bonda WLM. Inhaled sedation in the intensive care unit. Anaesth Crit Care Pain Med. 2022 Oct;41(5):101133. doi: 10.1016/j.accpm.2022.101133. Epub 2022 Jul 27. PubMed 35907598 ↗
  • Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC. PubMed 27611637 ↗
  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. PubMed 30113379 ↗
08

Registry details

Key details

Study ID
NCT07734350
Lead sponsor
Hospital H+ Queretaro
Responsible party
Jose J Zaragoza, MD MSc (Principal Investigator, Hospital H+ Queretaro) — Principal investigator
First posted
Jul 29, 2026
Start date
Jul 29, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Jul 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion