Clinical trial NCT00638729: Clonidine Versus Midazolam for Premedication
Official title: Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Keywords: bispectral index
sedation
stress hormones
cognitive function
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* elective surgery
* ASA physical status I and II
* informed consent
* weight 50 - 100 kg

Exclusion Criteria:

* cardiovascular disease
* pregnancy
* problems of consent due to mentally handicap or language.

Primary outcomes:
measure: Effect of premedication on bispectral index
timeFrame: prior study medication until 2 h postoperatively
Secondary outcomes:
measure: Effect of premedication on postoperative recovery
timeFrame: prior to study medication until 2 h postoperatively
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
Study officials:
affiliation: Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
name: Jens Scholz, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: Carabine 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.
citation: Ghignone 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.
citation: Grottke 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.
citation: Liu 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.
citation: Brosius 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.
citation: Lindahl 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.