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Sponsored by: |
Duke University |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00333632 |
The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine administered to surgical patients intra-operatively will improve the characteristics of sleep post-operatively.
Condition | Intervention | Phase |
---|---|---|
Sleep |
Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Restorative Sleep: Effect of Dexmedetomidine |
Estimated Enrollment: | 60 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2007 |
Physiological similarities exist between the anesthetized state and sleep. Pathways within the brain controlling sleep and wakefulness are also affected by anesthesia. One significant difference between the states of anesthesia and sleep is the ability to respond whenever a relatively mild stimulus is applied, e.g. verbal command or gently shaking. Interestingly, this feature of arousability is seen when dexmedetomidine is used for sedation but is absent when alternative intravenous anesthetic agents, e.g. propofol, are used to provide similar degree of sedation. Recent studies have shown that dexmedetomidine acts on receptors located within the locus ceruleus, which are responsible for both sleep and anesthesia.
During a recent study volunteers received an infusion of dexmedetomidine during the afternoon prior to remaining under study conditions for the duration of the night. The study was not designed to measure sleep but anecdotal reporting from the participants suggested that they were able to resume their normal day’s activities whilst the subject receiving placebo felt extremely fatigued from lack of sleep. This prompted the establishment of a pilot study to determine if dexmedetomidine could provide restorative sleep to people under disturbed sleep conditions i.e. postoperative patients.
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keita Ikeda, PhD | 919-812-5043 | ikeda002@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: David B MacLeod, MD 919-681-6437 david.macleod@duke.edu | |
Contact: Keita Ikeda, PhD 919-812-5043 ikeda002@mc.duke.edu |
Principal Investigator: | David B MacLeod, MD | Duke University |
Study ID Numbers: | 8306 |
Study First Received: | June 2, 2006 |
Last Updated: | July 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00333632 |
Health Authority: | United States: Institutional Review Board |
Sleep Dexmedetomidine Postoperative care Sedation |
Fentanyl Isoflurane Dexmedetomidine Propofol Midazolam |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Adrenergic Agonists Pharmacologic Actions |
Anesthetics, Inhalation Anesthetics, General Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents |