Contact information
Type
Scientific
Primary contact
Dr Patrick Meybohm
ORCID ID
Contact details
University Hospital Schleswig-Holstein
Campus Kiel
Schwanenweg 21
Kiel
24105
Germany
meybohm@anaesthesie.uni-kiel.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
premedication
Study hypothesis
We hypothesised that:
1. 50 mg chlorazepate dipotassium at 10 pm evening before surgery prevent an increase of anxiety and sympatho-adrenal activity at morning of surgery sufficiently, and
2. A fixed-time application of chlorazepate dipotassium at 7 am morning of surgery may be superior compared to administration of midazolam 30 minutes prior to induction of anesthesia with respect to level of anxiety, sympatho-adrenal activity and conscious sedation.
Ethics approval
The trial was approved by the local ethics committee of the University Kiel on the 3rd April 2002 (reference number: AZ 142/01).
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Premedication, Anaesthesia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Chlorazepate dipotassium and midazolam
Primary outcome measures
1. Level of anxiety
2. Sympatho-adrenal activity (plasma levels of Adrenocorticotropic Hormone [ACTH], cortisol, norepinephrine and epinephrine)
Secondary outcome measures
1. Haemodynamic data
2. Oxygen saturation
3. Conscious sedation
4. Bispectral index
Overall trial start date
01/05/2003
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant 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
Recruitment start date
01/05/2003
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Schleswig-Holstein
Kiel
24105
Germany
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Schleswig-Holstein (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary