Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Fixed-time chlorazepate dipotassium premedication versus midazolam on demand: a randomised, controlled trial
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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Chlorazepate dipotassium and midazolam
Primary outcome measure
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 study start date
01/05/2003
Overall study end date
01/10/2004
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
50
Total final enrolment
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
Study participating centre
University Hospital Schleswig-Holstein
Kiel
24105
Germany
Sponsor information
Organisation
University Hospital Schleswig-Holstein (Germany)
Sponsor details
Campus Kiel
Department of Anaesthesiology and Intensive Care Medicine
Schwanenweg 21
Kiel
24105
Germany
Sponsor type
Hospital/treatment centre
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2007 | 26/03/2021 | Yes | No |