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

NCT04983615 | Completed

• 1 other identifier: 0114-21-MMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanically Ventilated Patients

Keywords

opioid-based sedation, delirium

Outcome Measures

Primary Outcomes (1)

• RASS score

  comparison of delirium score between the groups

  1 year

Study Arms (2)

fentanyl-based sedation group

EXPERIMENTAL

Drug: fentanyl-based sedation

midazolam-based sedation group

ACTIVE COMPARATOR

Drug: midazolam-based sedation

Interventions

fentanyl-based sedation DRUG

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

fentanyl-based sedation group

midazolam-based sedation DRUG

midazolam-based sedation

midazolam-based sedation group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir medical center Kfar Saba

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sara Dichtwald, Dr

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 30, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)