Effect of Dexmedetomidine Upon Sleep Postoperatively
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Restorative Sleep: Effect of Dexmedetomidine |
- Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale
- Completion of sleep log
- Subjects will also be asked to complete Visual Analogue Scales (VAS) of sleep and daytime sleepiness.
- The quality of postoperative recovery (QoR) and the presence of fatigue (Brief Fatigue Inventory)
- Subjects will also be asked to complete Visual Analogue Scale (VAS) of fatigue.
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2011 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- scheduled to undergo elective lower extremity orthopaedic surgery (free vascular fibular graft)
- ASA 1 or 2
- Body Mass Index 20 - 30
- Procedure to be done under combined epidural and general anesthesia
Exclusion Criteria:
- Sleep disturbance
- Insomnia
- Sleep apnea
- Female (pregnant)
- Contra-indication to placement of epidural anesthesia
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | David B MacLeod, MD | Duke University |
More Information
No publications provided
| Responsible Party: | David B. MacLeod, Associate Faculty, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00333632 History of Changes |
| Other Study ID Numbers: | 8306 |
| Study First Received: | June 2, 2006 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Sleep Dexmedetomidine Postoperative care Sedation |
Additional relevant MeSH terms:
|
Midazolam Fentanyl Propofol Dexmedetomidine Isoflurane Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Anesthetics, Inhalation Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists |
ClinicalTrials.gov processed this record on June 17, 2013