Condition category
Surgery
Date applied
13/12/2006
Date assigned
13/02/2007
Last edited
13/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes