PRECEDEX SUMMARY
Precedex® (dexmedetomidine hydrochloride injection) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride.
Intensive Care Unit Sedation
Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.
Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.
Procedural Sedation
Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
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NEWS HIGHLIGHTS
Published Studies Related to Precedex (Dexmedetomidine)
Perioperative infusion of dexmedetomidine at a high dose reduces postoperative analgesic requirements: a randomized control trial. [2011.09.28]
PURPOSE: We hypothesized that a high dose of dexmedetomidine (1 mug/kg/h) could reduce postoperative analgesic requirements of patients... CONCLUSIONS: Among this small patient cohort, perioperative infusion of dexmedetomidine (1 mug/kg/h) resulted in antinociception without severe side effects. These results suggest that this method could be of interest with respect to improving postoperative pain status.
A randomized, blinded, controlled trial of the antiemetic effect of ondansetron on dexmedetomidine-induced emesis in cats. [2011.07]
OBJECTIVE: To determine the effect of ondansetron on the incidence of vomiting in cats pre-medicated with dexmedetomidine and buprenorphine.
Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. [2011.06]
Presurgery anxiety in children may result in preoperative and postoperative complications...
High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. [2011.06]
PURPOSE: Dexmedetomidine, a selective alpha(2) adrenoreceptor agonist, has analgesic and sedative properties, minimal impact on respiratory parameters, and reportedly decreases analgesic requirements after surgery. Given its pharmacodynamic profile, dexmedetomidine might have a role for postoperative pain control in children undergoing tonsillectomy. In this study, we hypothesized that dexmedetomidine would delay and decrease opioid requirements after tonsillectomy... CONCLUSIONS: High-dose dexmedetomidine decreases opioid requirements, prolongs the opioid-free interval after tonsillectomy, and prolongs length of stay in the postanesthesia care unit. It is conceivable that these early opioid-sparing effects could benefit patients at risk for respiratory complications early in the postoperative course after tonsillectomy (e.g., patients with obstructive sleep apnea). (ClinicalTrials.gov number, NCT00654511).
Dexmedetomidine: an alternative for epidural anesthesia in tension-free vaginal-tape surgery. [2011.06]
PURPOSE: Anesthetic management of tension-free vaginal-tape (TVT) procedures is sometimes difficult to deal with, especially when surgeons request a cough test. Dexmedetomidine has unique sedative and analgesic properties while having minimal respiratory effects, making it suitable for perioperative use in monitored anesthesia care. We aimed to compare dexmedetomidine and epidural anesthesia in TVT patients... CONCLUSION: Dexmedetomidine can be an alternative to epidural anesthesia in TVT procedure requiring cough test.
Clinical Trials Related to Precedex (Dexmedetomidine)
Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery [Not yet recruiting]
Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery,
will improve patient management through the anesthesia postoperative recovery period
determined by improvement in patients? tolerance of the endotracheal tube.
Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery
will provide improved hemodynamic stability.
Awake Intubation - Precedex Used for Sedation During Elective Awake Fiberoptic Intubation [Active, not recruiting]
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal [Not yet recruiting]
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol
withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive
dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while
maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a
dose-dependent profile of action when it is used for this indication. In addition, this
study will assess the relationships between alcohol withdrawal, therapy with
dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion [Recruiting]
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay
discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory
effects. This study will evaluate whether DEX can help get patients out of the hospital
faster after major spine surgery by reducing the inflammation associated with the procedure
itself. A separate part of the study will evaluate the blood levels of some specific
indicators of inflammation called cytokines. Measuring cytokines before and after surgery
will aid in determining if DEX has altered the inflammatory response.
Dexmedetomidine in Seizure Patients [Recruiting]
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique
properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical
patients frequently come to the operating room on anticonvulsant therapy with a history of
seizures. The investigators clinical experience suggests that these patients are resistant
to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic
interaction between the anticonvulsant medications and dexmedetomidine or the higher
dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the
underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic
and pharmacodynamic differences of dexmedetomidine between patients receiving and not
receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for
these differences.
Reports of Suspected Precedex (Dexmedetomidine) Side Effects
Cardiac Arrest (6),
Bradycardia (5),
Procedural Complication (4),
Agitation (3),
Hyperthermia (3),
Musculoskeletal Stiffness (3),
Blood Creatine Phosphokinase Increased (2),
Acidosis (2),
Hepatitis Fulminant (2),
Peripheral Circulatory Failure (2), more >>
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