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Opioid vs. Benzodiazepine-based Sedation for Mechanically Ventilated Patients in the Internal Medicine Ward

Opioid vs. Benzodiazepine-based Sedation for Mechanically Ventilated Patients in the Internal Medicine Ward

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04983615
Enrollment
50
Registered
2021-07-30
Start date
2021-08-01
Completion date
2024-08-01
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated Patients

Keywords

opioid-based sedation, delirium

Brief summary

Opioid-based sedation as a first line in mechanically ventilated patients has been considered the gold standard in intensive care unit patients around the world for several decades. Advantages of opiate-based sedation, compared to benzodiazepine-based sedation, which has been used in the past, include a reduction in delirium scores, better pain control, decreasing the time between cessation of sedation and patient awakening, and decreasing the time between cessation of sedation and extubation, with decreased ICU admission times. In most Western European countries, as well as in the United States, there are almost no mechanically ventilated patients hospitalized outside the intensive care unit. In a few countries, including Japan and Israel, mechanically ventilated patients are also hospitalized outside of intensive care units, as part of internal or surgical wards. Contrary to the vast knowledge accumulated regarding different sedation methods in ventilated patients in intensive care units, there are almost no studies that have evaluated different sedation methods in ventilated patients hospitalized in non-intensive care wards. Thus, while there is consensus on the benefits of opioid-based sedation in intensive care units, there is insufficient information to recommend the preferred sedation method in non-ICU wards. For various reasons, in a large number of the internal medicine wards of hospitals in Israel, the common sedation practice for ventilated patients is still benzodiazepine-based sedation. In the past year, a pilot program was initiated in Internal Medicine Department A at Meir Hospital in Kfar Saba, in which a new protocol for opioid-based sedation in ventilated patients was implemented. The protocol is based on the continuous intravenous infusion of fentanyl as the first line of treatment for sedation in ventilated patients only. If the sedation-agitation level (as measured by the RASS score) did not match the target RASS score set by the attending physician, a dose up to a maximum limit could be increased according to the protocol. Second-line sedation drugs were addition of continuous intravenous infusion of midazolam (in addition to fentanyl) in hemodynamically stable patients, or addition of continuous intravenous infusion of ketamine in unstable patients. In stable patients who did not reach the desired RASS level under continuous infusion of fentanyl and midazolam, ketamine could be added as a third line drug, in addition to fentanyl and midazolam.

Interventions

DRUGfentanyl-based sedation

fentanyl-based sedation instead of midazolam-based sedation in ventilated patients

DRUGmidazolam-based sedation

midazolam-based sedation

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

Patients aged 18-99 who were admitted to Internal Medicine Department A at Meir Hospital in Kfar Saba from January 2020 to January 2021 (inclusive), and required mechanical ventilation. \-

Exclusion criteria

Patients who were sedated and ventilated for palliative care only without any fututre plan for weaning them of ventilation, or patients in whom there was a deviation from the treatment protocol \-

Design outcomes

Primary

MeasureTime frameDescription
RASS score1 yearcomparison of delirium score between the groups

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026