Main objectiveLorazepam is frequently used as an anaesthesiological premedication before surgery in order to reduce patients resistance. Does lorazepam also improve the quality of recovery in patients scheduled for day-case-surgery?Secondary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
De weerstand van de patiënt t.o.v. de operatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of recovery, aggression, anxiety, fatigue, depression symptoms.
Secondary outcome
pharmacogenetic background lorazepam
Background summary
Almost all patients, who undergo a surgery, shrink from the surgery (also
called resistance). Resistance expressess itself in anxiety, depression
symptoms, aggression, fatigue and somatic symptoms. Determinants; demografic,
medical, psychological and genetic features; of resistance can affect the
expression of patients resistance.
At this moment it is not standardized to give anxiolytic premedication before
day-case-surgery. 19% of day-case-surgery patients want something to reduce
preoperative anxiety. We want to design a decision model to answer the question
which patients are vulnerable and/of have benefit from receiving preoperative
lorazepam.
Study objective
Main objective
Lorazepam is frequently used as an anaesthesiological premedication before
surgery in order to reduce patients resistance. Does lorazepam also improve the
quality of recovery in patients scheduled for day-case-surgery?
Secondary objective
Developping a prognostic model, which tells us which patients are vulnerable
and/of need (lorazepam as) premedication before surgery.
Study design
Randomised Controlled Trial, parallel group, double blind, placebo, controlled
Intervention
One group receives once 1-1.5 mg lorazepam before surgery, depending on body
weight. The other group receives once placebo (NaCl) before surgery.
Study burden and risks
Once one blood sample of 10 ml (not extra invasive). Patients have to fill in
some not intimidating questionnaires at 4 different moments. This will be about
40 minutes to fill in, scattered over a period of 7 working days.
Beukelsweg 19B 2
3022 GB Rotterdam
NL
Beukelsweg 19B 2
3022 GB Rotterdam
NL
Listed location countries
Age
Inclusion criteria
age >= 18 years, day-case surgery patients
Exclusion criteria
Patients with the following features: mental retardation, language barrier.
Patients who undergo the following interventions: surgery of the eye, MDL surgery, ESWL treatment, chronic pain relief treatment.
Patients who take psychofarmaca.
Contra-indications for lorazepam use, like Myasthenia Gravis and liver disease, will be excluded too.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020332-19-NL |
| CCMO | NL32535.078.10 |