AnxietyNCT00638729
Clonidine Versus Midazolam for Premedication
A study testing midazolam and clonidine in people with Anxiety and Pain, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- midazolam and clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery
- ASA physical status I and II
- informed consent
- weight 50 - 100 kg
Who cannot join
- cardiovascular disease
- pregnancy
- problems of consent due to mentally handicap or language.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
Kiel, 24105
About this study
Official title: Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery
alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.
- Being tested
- midazolam, clonidine, placebo
- Keywords
- bispectral index, sedation, stress hormones, cognitive function
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called Dormicum
midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
clonidineDrug
Also called Catapresan
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
placeboDrug
inert tablet p.o., 60-90 min prior to estimated induction time
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time Receives: Drug: midazolam |
| Clonidine | Active comparator | pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time Receives: Drug: clonidine |
| Placebo | Placebo comparator | Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of premedication on bispectral index
Measured: prior study medication until 2 h postoperatively
Secondary outcomes (1)
Effect of premedication on postoperative recovery
Measured: prior to study medication until 2 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startAug 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Jens Scholz, M.D., Study chair, Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638729
- Sponsor's protocol ID
- A 157/01
- Other IDs
- A 157/01
- Status last verified
- Feb 2008
- First submitted
- 12 Mar 2008
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Matot I, Sichel JY, Yofe V, Gozal Y. The effect of clonidine premedication on hemodynamic responses to microlaryngoscopy and rigid bronchoscopy. Anesth Analg. 2000 Oct;91(4):828-33. doi: 10.1097/00000539-200010000-00011.
PubMed 11004033Carabine UA, Milligan KR, Moore JA. Adrenergic modulation of preoperative anxiety: a comparison of temazepam, clonidine, and timolol. Anesth Analg. 1991 Nov;73(5):633-7. doi: 10.1213/00000539-199111000-00021.
PubMed 1683183Ghignone M, Quintin L, Duke PC, Kehler CH, Calvillo O. Effects of clonidine on narcotic requirements and hemodynamic response during induction of fentanyl anesthesia and endotracheal intubation. Anesthesiology. 1986 Jan;64(1):36-42. doi: 10.1097/00000542-198601000-00007.
PubMed 3942335Grottke O, Muller J, Dietrich PJ, Krause TH, Wappler F. [Comparison of premedication with clonidine and midazolam combined with TCI for orthopaedic shoulder surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003 Dec;38(12):772-80. doi: 10.1055/s-2003-45396. German.
PubMed 14666440Liu J, Singh H, White PF. Electroencephalogram bispectral analysis predicts the depth of midazolam-induced sedation. Anesthesiology. 1996 Jan;84(1):64-9. doi: 10.1097/00000542-199601000-00007.
PubMed 8572355Brosius KK, Bannister CF. Oral midazolam premedication in preadolescents and adolescents. Anesth Analg. 2002 Jan;94(1):31-6, table of contents. doi: 10.1097/00000539-200201000-00006.
PubMed 11772796Lindahl SG. The use of midazolam in premedication. Acta Anaesthesiol Scand Suppl. 1990;92:79-83; discussion 107. doi: 10.1111/j.1399-6576.1990.tb03191.x.
PubMed 2183537
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery
- ClinicalTrials.gov ID
- NCT00638729
- Acronym / sponsor ID
- A 157/01
- Keywords
- bispectral index, sedation, stress hormones, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: midazolamPre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time |
| Clonidine | Active comparator | Drug: clonidinepre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time |
| Placebo | Placebo comparator | Drug: placeboPre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective surgery
- ASA physical status I and II
- informed consent
- weight 50 - 100 kg
Key exclusion criteria (3 listed)
- cardiovascular disease
- pregnancy
- problems of consent due to mentally handicap or language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamAlso: Dormicummidazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time | Drug | Midazolam |
| clonidineAlso: Catapresanpre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time | Drug | Clonidine |
| placeboinert tablet p.o., 60-90 min prior to estimated induction time | Drug | Placebo |
Primary outcome
Effect of premedication on bispectral index
Time frame: prior study medication until 2 h postoperatively
1 secondary outcome
Effect of premedication on postoperative recovery
Time frame: prior to study medication until 2 h postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
- Background: PubMed 11004033Matot I, Sichel JY, Yofe V, Gozal Y. The effect of clonidine premedication on hemodynamic responses to microlaryngoscopy and rigid bronchoscopy. Anesth Analg. 2000 Oct;91(4):828-33. doi: 10.1097/00000539-200010000-00011.
- Background: PubMed 1683183Carabine UA, Milligan KR, Moore JA. Adrenergic modulation of preoperative anxiety: a comparison of temazepam, clonidine, and timolol. Anesth Analg. 1991 Nov;73(5):633-7. doi: 10.1213/00000539-199111000-00021.
- Background: PubMed 3942335Ghignone M, Quintin L, Duke PC, Kehler CH, Calvillo O. Effects of clonidine on narcotic requirements and hemodynamic response during induction of fentanyl anesthesia and endotracheal intubation. Anesthesiology. 1986 Jan;64(1):36-42. doi: 10.1097/00000542-198601000-00007.
- Background: PubMed 14666440Grottke O, Muller J, Dietrich PJ, Krause TH, Wappler F. [Comparison of premedication with clonidine and midazolam combined with TCI for orthopaedic shoulder surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003 Dec;38(12):772-80. doi: 10.1055/s-2003-45396. German.
- Background: PubMed 8572355Liu J, Singh H, White PF. Electroencephalogram bispectral analysis predicts the depth of midazolam-induced sedation. Anesthesiology. 1996 Jan;84(1):64-9. doi: 10.1097/00000542-199601000-00007.
- Background: PubMed 11772796Brosius KK, Bannister CF. Oral midazolam premedication in preadolescents and adolescents. Anesth Analg. 2002 Jan;94(1):31-6, table of contents. doi: 10.1097/00000539-200201000-00006.
- Background: PubMed 2183537Lindahl SG. The use of midazolam in premedication. Acta Anaesthesiol Scand Suppl. 1990;92:79-83; discussion 107. doi: 10.1111/j.1399-6576.1990.tb03191.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Scholz, M.D. study chair
Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam and clonidine in people with Anxiety and Pain, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of premedication on bispectral index (time frame: prior study medication until 2 h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638729, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2008.