Study of protocolized lighter sedation during open abdomen management

Study of protocolized lighter sedation during open abdomen management - Study of protocolized lighter sedation during open abdomen management

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053669

Enrollment

Registered

2024-02-21

Start date

2024-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

acute abdomen

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patient admitted to ICU with OAM after surgery for acute abdomen due to endogenous disease

Exclusion criteria

Exclusion criteria: Patients with abdominal compartment syndrome, patients receiving continuous muscle relaxants

Design outcomes

Primary

Measure	Time frame
The co-primary outcomes were time spent under light sedation (Richmond Agitation and Sedation Scale [RASS] -2 to 0) during OAM, and propofol dosage (mg/kg/hr) during OAM.	—

Secondary

Measure	Time frame
Secondary outcomes included analgesics and sedatives exposure other than propofol, time from abdominal closure to weaning from mechanical ventilation, length of ICU stay, length of hospital stay, in-hospital mortality, tracheotomy performed during ICU stay, days spent under coma (defined as -4 or -5 of RASS throughout the day) during OAM, delirium (defined as at least one positive Confusion Assessment Method for the Intensive Care Unit [CAM-ICU]) during OAM, vasopressor administration during ICU stay, and kidney replacement therapy during ICU stay. We also evaluated adverse events during OAM, defined as bleeding or disruption of abdominal dressings requiring urgent intra-abdominal observation and dressing replacement.	—

Measure

Time frame

Secondary outcomes included analgesics and sedatives exposure other than propofol, time from abdominal closure to weaning from mechanical ventilation, length of ICU stay, length of hospital stay, in-hospital mortality, tracheotomy performed during ICU stay, days spent under coma (defined as -4 or -5 of RASS throughout the day) during OAM, delirium (defined as at least one positive Confusion Assessment Method for the Intensive Care Unit [CAM-ICU]) during OAM, vasopressor administration during ICU stay, and kidney replacement therapy during ICU stay. We also evaluated adverse events during OAM, defined as bleeding or disruption of abdominal dressings requiring urgent intra-abdominal observation and dressing replacement.

—

Countries

Japan

Contacts

Public ContactJunichi Fukushima

Wakayama Medical University Department of Emergency and Critical Care Medicine

ow.junichi.1125@gmail.com073-447-2300

Outcome results