Fixed-time chlorazepate dipotassium premedication versus midazolam on demand: a randomised, controlled trial
| ISRCTN | ISRCTN39991569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39991569 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/12/2006
- Registration date
- 13/02/2007
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Patrick Meybohm
Scientific
Scientific
University Hospital Schleswig-Holstein
Campus Kiel
Schwanenweg 21
Kiel
24105
Germany
| meybohm@anaesthesie.uni-kiel.de |
Study information
| 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 |
| Scientific title | Fixed-time chlorazepate dipotassium premedication versus midazolam on demand: a randomised, controlled trial |
| Study acronym | premedication |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital Schleswig-Holstein
Kiel
24105
Germany
24105
Germany
Sponsor information
University Hospital Schleswig-Holstein (Germany)
Hospital/treatment centre
Hospital/treatment centre
Campus Kiel
Department of Anaesthesiology and Intensive Care Medicine
Schwanenweg 21
Kiel
24105
Germany
"ROR" |
https://ror.org/01tvm6f46 |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospital Schleswig-Holstein (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2007 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
