Precedex (Dexmedetomidine Hydrochloride) - Summary

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

Media Articles Related to Precedex (Dexmedetomidine)

AcelRx Announces Positive Results From A Phase 2 Study Of ARX-03, A Sufentanil/Triazolam NanoTab For Procedural Sedation, Anxiolysis & Analgesia
Source: Anxiety / Stress News From Medical News Today [2009.10.23]
AcelRx Pharmaceuticals, Inc. announced positive results from a Phase 2 clinical trial of ARX-03, a proprietary sublingual dosage form combining an opioid, sufentanil, with a benzodiazepine, triazolam. ARX-03 is designed to address the current unmet need for a non-invasive product to provide mild sedation, anxiolysis and analgesia with rapid onset of action for the increasing number of painful and anxiety-producing office-based procedures.

Unsedated Colonoscopy For Colorectal Cancer Screening Well Accepted By Patients
Source: Colorectal Cancer News From Medical News Today [2009.10.28]
Researchers from Taiwan report in a new study that unsedated colonoscopy for primary colorectal cancer screening is well accepted in a majority of patients. Sedation is typically used for colonoscopy to make the patient feel comfortable during the procedure. In Taiwan, colonoscopy is performed less frequently than sigmoidoscopy for colorectal cancer screening due to concerns over cost and availability.

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Published Studies Related to Precedex (Dexmedetomidine)

Prevalence of Delirium with Dexmedetomidine Compared with Morphine Based Therapy after Cardiac Surgery: A Randomized Controlled Trial (DEXmedetomidine COmpared to Morphine-DEXCOM Study). [2009.09.25]
BACKGROUND:: Commonly used sedatives/analgesics can increase the risk of postoperative complications, including delirium. This double-blinded study assessed the neurobehavioral, hemodynamic, and sedative characteristics of dexmedetomidine compared with morphine-based regimen after cardiac surgery at equivalent levels of sedation and analgesia... CONCLUSION:: Dexmedetomidine reduced the duration but not the incidence of delirium after cardiac surgery with effective analgesia/sedation, less hypotension, less vasopressor requirement, and more bradycardia versus morphine regimen.

Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children. [2009.08]
BACKGROUND: Caudal block is a common technique for paediatric analgesia but with the disadvantage of short duration of action after single injection. Caudal dexmedetomidine and clonidine could offer significant analgesic benefits. We compared the analgesic effects and side-effects of dexmedetomidine and clonidine added to bupivacaine in paediatric patients undergoing lower abdominal surgeries... CONCLUSIONS: Addition of dexmedetomidine or clonidine to caudal bupivacaine significantly promoted analgesia in children undergoing lower abdominal surgeries with no significant advantage of dexmedetomidine over clonidine and without an increase in incidence of side-effects.

The effects of dexmedetomidine and fentanyl on emergence characteristics after adenoidectomy in children. [2009.07]
This randomised controlled study evaluated the effects of fentanyl and dexmedetomidine on emergence characteristics of children having adenoidectomy and anaesthetised with sevoflurane. Ninety children, two to seven years of age and ASA physical status I, were studied.Further studies of dexmedetomidine safety and its interaction with other anaesthetic agents are required before recommending its routine use during general anaesthesia in children.

Intranasal dexmedetomidine premedication is comparable with midazolam in burn children undergoing reconstructive surgery. [2009.07]
Preoperative anxiety and emergence delirium in children continue to be common even with midazolam premedication. Midazolam is unpleasant tasting even with a flavored vehicle and as a result, patient acceptance is sometimes poor...

Clinical evaluation of the efficacy and safety of a constant rate infusion of dexmedetomidine for postoperative pain management in dogs. [2009.07]
OBJECTIVE: To compare postoperative analgesia provided by a constant rate infusion (CRI) of dexmedetomidine (DMED) to that of a well-established positive control [morphine (MOR)] in critically ill dogs. The sedative, cardiorespiratory effects and clinical safety of a 24-hour DMED CRI were also evaluated...

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Clinical Trials Related to Precedex (Dexmedetomidine)

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 for the Control of Post-Operative Pain in Thoracotomy Patients [Recruiting]
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy [Recruiting]
The primary purpose of this study is:

1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.

2. To determine an analgesic dose response relationship for dexmedetomidine.

3. Compare recovery characteristics of dexmedetomidine to fentanyl.

Dexmedetomidine for Peri-Operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT) [Recruiting]
Relative to placebo or fentanyl,

1. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 micrograms/kilogram, will provide superior postoperative sedation as measured by post-operative agitation, pain scores and reduced need for rescue analgesia.

2. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 microgram/kilogram, will produce a more favorable time to emergence and readiness for discharge from Recovery Phase I and Phase II.

3. There will be no clinically significant difference in hemodynamic measures including heart rate and blood pressure, among the four treatment groups either intraoperatively, or during the recovery period (Recovery Phase I and Phase II).

Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine [Recruiting]
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

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