Premedication, Anaesthesia Surgery Anaesthesia
Conditions
Interventions
Patients were randomised to one of two groups:
1. Group CCP: at Evening Before Surgery (EBS) clorazepate dipotassium 50 mg orally (Tranxilium®
Sanofi-Aventis GmbH, Frankfurt am Main, Germany)
at Morning Of Surgery (MOS) clorazepate dipotassium 25 mg orally
and before Induction of Anesthesia (AI) placebo orally
2. Group CPM: at EBS clorazepate dipotassium 50 mg orally
at MOS placebo orally
before AI midazolam 7.5 mg orally (Dormicum®
Roche, Mijdrecht, The Netherlands)
Dosages of clorazepate dipotassium in our study were based on recommendations that have been published previously.
Sponsors
University Hospital Schleswig-Holstein (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with an American Society of Anaesthesiologists (ASA) physical status of one or two 2. Aged between 18 and 55 years 3. Weighing from 60 to 88 kg 4. Scheduled to undergo an elective surgical, orthopaedic or urologic procedure in general anesthesia
Exclusion criteria
Exclusion criteria: 1. Sleep apnoea syndrome 2. Pregnancy 3. Use of sedative, stimulant, or other medications within the previous month 4. The presence of neurological, renal, or hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Level of anxiety 2. Sympatho-adrenal activity (plasma levels of Adrenocorticotropic Hormone [ACTH], cortisol, norepinephrine and epinephrine) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemodynamic data 2. Oxygen saturation 3. Conscious sedation 4. Bispectral index | — |
Countries
Germany
Outcome results
None listed