C00-C14
Conditions
Interventions
Group 1: This study had one prospective nonblinded arm (lormetazepam group) including 19 patients scheduled for ENT free flap surgery and a retrospective control group with 20 patients receiving propo
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Planned sedation and mechanical ventilation for more than 24 hours (up to 168 hours) following ENT tumor resection at Heidelberg University Hospital.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to lormetazepam, other benzodiazepines, or any of the other ingredients - Total sedation duration >168 hours - Breastfeeding - Myasthenia gravis - Acute poisoning with alcohol, sleeping pills, painkillers, psychotropic drugs (neuroleptics, antidepressants, lithium salts) - History of dependence (alcohol, medicines, drugs) - Known pregnancy or positive pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative delirium, ICDSC three times daily Recording of the ICDSC (ICU Delirium Screening Checklist) every eight hours over 7 days postoperatively. The ICDSC is a scoring system for the early detection of delirium in critically ill patients in intensive care units. It records 8 parameters such as altered consciousness, inattention, disorientation, hallucinations, agitation, inappropriate speech, sleep disturbance, and fluctuating symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular stability, catecholamine requirement Circulatory parameters such as blood pressure and heart rate, as well as catecholamine requirements, were recorded every 20 minutes over a period of 7 days. | — |
Countries
Germany
Contacts
Public ContactCornelius Busch
Universitätsklinikum Heidelberg
Outcome results
None listed