SUFENTANIL SUMMARY
Preservative-Free
SUFENTANIL
CITRATE
Injection, USP
50 mcg/mL Sufentanil
Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection. Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner.
Sufentanil Citrate Injection, USP is indicated for intravenous administration:
As an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
As a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
Sufentanil Citrate Injection, USP is indicated for epidural administration as an analgesic combined with low dose bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery.
SEE DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTANIL.
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NEWS HIGHLIGHTSMedia Articles Related to Sufentanil (Sufentanil Epidural)
Patients With Sleep Apnea Undergoing Joint Replacement Have Improved Outcomes With Regional Anesthesia
Source: Arthritis / Rheumatology News From Medical News Today [2013.05.07]
Using regional anesthesia instead of general anesthesia in patients with sleep apnea undergoing total joint replacement decreases major complications by 17%, according to a study published online, ahead of print, in the journal Regional Anesthesia and Pain Medicine...
Lower Rates Of Complications In Hip And Knee Replacement Using Regional Anesthesia Technique
Source: Arthritis / Rheumatology News From Medical News Today [2013.05.03]
A highly underutilized anesthesia technique called neuraxial anesthesia, also known as spinal or epidural anesthesia, improves outcomes in patients undergoing hip or knee replacement, according to a new study by researchers at Hospital for Special Surgery...
General Anesthesia Not Linked to Raised Risk for Dementia
Source: MedicineNet Dementia Specialty [2013.05.02]
Title: General Anesthesia Not Linked to Raised Risk for Dementia
Category: Health News
Created: 5/1/2013 12:35:00 PM
Last Editorial Review: 5/2/2013 12:00:00 AM
Success Rates Of Turning Breech Babies Increased By Anesthesia, Delivery Costs Reduced
Source: Pain / Anesthetics News From Medical News Today [2013.04.22]
When a baby is in the breech position at the end of pregnancy, obstetricians can sometimes turn the baby head-down to enable a safer vaginal birth. In the past, women were not given anesthesia during the turning procedure, which requires the physician to push on the woman's abdomen while monitoring the baby with ultrasound...
Development Of Wisdom Teeth In Children May Be Affected By Dental Anesthesia
Source: Dentistry News From Medical News Today [2013.04.05]
Researchers from Tufts University School of Dental Medicine have discovered a statistical association between the injection of local dental anesthesia given to children ages two to six and evidence of missing lower wisdom teeth...
Published Studies Related to Sufentanil (Sufentanil Epidural)
Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labour. [2011.09]
We studied the potentiation of analgesia for labour by the addition of clonidine to epidural low-concentration levobupivacaine with sufentanil in a randomised, double-blinded study. We enrolled primiparous women who were in spontaneous labour...
Comparison of intrathecal bupivacaine and ropivacaine with different doses of sufentanil. [2011.07]
BACKGROUND: Spinal bupivacaine produces a complete anaesthetic block of a longer duration than ropivacaine, which leads to a potentially increased risk of failure. A combination of sufentanil to ropivacaine may improve the block's reliability... CONCLUSION: Plain bupivacaine 10 mg has a longer recovery profile than the same dose of ropivacaine with or without sufentanil. (c) 2011 The Authors. Acta Anaesthesiologica Scandinavica (c) 2011 The Acta Anaesthesiologica Scandinavica Foundation.
A randomised comparison of intravenous remifentanil patient-controlled analgesia with epidural ropivacaine/sufentanil during labour. [2011.04]
BACKGROUND: The mu-opioid agonist remifentanil has a rapid onset and offset and a short half-life making it an attractive option for intravenous patient-controlled labour analgesia. We aimed to compare the efficacy of intravenous remifentanil patient-controlled analgesia with epidural ropivacaine/sufentanil during labour... CONCLUSIONS: In the 20 patients recruited to this study, pain relief in labour with epidural ropivacaine/sufentanil was more effective than with intravenous remifentanil patient-controlled analgesia. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
Sedation with sufentanil and clonidine in patients undergoing heart catheterization. [2011.03]
BACKGROUND: Sedation for heart catheterization has been a cause for concern. Benzodiazepines, alpha-2 adrenergic agonists and opioids are used for this purpose. However, each drug has advantages and disadvantages. OBJECTIVE: To evaluate the efficacy of sufentanil and clonidine as sedative in patients undergoing heart catheterization, observing their impact on hemodynamic and respiratory parameters, the presence of side effects and satisfaction of the patient and interventional cardiologist with the examination... CONCLUSION: Sufentanil and clonidine were effective as sedative in patients undergoing heart catheterization.
Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. [2011.03]
BACKGROUND: The effects of an epidural opioid and a local anesthetic on the perioperative stress responses have not been fully investigated in elderly patients undergoing cancer surgery. We hypothesized that the stress response after a radical retropubic prostatectomy (RRP) would be attenuated by epidural ropivacaine and sufentanil... CONCLUSION: Epidural ropivacaine blunted the perioperative stress responses in elderly patients undergoing a RRP. The combination of epidural ropivacaine and sufentanil was associated with the most pronounced attenuation of the stress response. ClinicalTrial.gov registration number: NCT01086956. (c) 2010 The Authors. Journal compilation (c) 2010 The Acta Anaesthesiologica Scandinavica Foundation.
Clinical Trials Related to Sufentanil (Sufentanil Epidural)
A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain [Recruiting]
A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation. [Terminated]
This prospective, randomized, multicenter, open-label study will compare two analgesia-based
regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term
ventilated intensive care patients in terms of efficacy, safety and resource utilization.
The special characteristics of intensive care patients (organ insufficiencies etc.) regularly
cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this
complicates the calculation of weaning and extubation times, often making mechanical
ventilation necessary for longer periods than desired and also extending the stay of patients
in the intensive care unit. Reducing weaning times and the duration of intensive care
treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical
complications such as ventilator-associated pneumonia or delirium.
The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary
depression and rapid onset of effect and in particular a short dura-tion of effect and
absence of accumulation or development of active metabolites. Remifentanil is an ultra-short
acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by
unspecific blood and tissue esterases with the substance being degraded within only a few
minutes and the resulting metabolites being virtually ineffective at the µ-receptor.
Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in
the liver and small intestine.
To date, only one study with a small sample size is available on the comparison of the
effectiveness and safety of remifentanil and sufentanil when used for long-term
analgesia/sedation.
Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System [Recruiting]
A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer [Not yet recruiting]
The study hypothesis is that the safety and efficacy of sufentanil following transdermal
application is comparable to sustained release morphine sulphate tablets in patients with
chronic pain due to cancer.
Pain Therapy After Elective Cardiac Surgery [Recruiting]
The purpose of this study is to determine generation of a target controlled infusion model
for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned
open heart surgery, during which the strong analgesic, sufentanil, was used.
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