Sufentanil (Sufentanil Citrate Epidural) - Summary

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 HIGHLIGHTS

Media Articles Related to Sufentanil (Sufentanil Epidural)

Abdominal Surgery Without General Anesthesia
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.11.04]
A recent review in Faculty of 1000 Medicine Reports, a publication in which clinicians highlight advances in medical practice, suggests regional pain relief could be used during abdominal surgery. In this review, Michael Schaefer recommends a new approach that can be performed without the need for general anaesthetics.

Anesthesia, Exertional Heat Deaths May Be Linked
Source: MedicineNet Hyperthermia Specialty [2009.10.26]
Title: Anesthesia, Exertional Heat Deaths May Be Linked
Category: Health News
Created: 10/23/2009 4:10:00 PM
Last Editorial Review: 10/26/2009

Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Source: MedicineNet Hernia Specialty [2009.03.25]
Title: Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Category: Health News
Created: 3/25/2009 2:00:00 AM
Last Editorial Review: 3/25/2009

Need For Emergency Airway Surgery For Hard-to-Intubate Patients Reduced
Source: Respiratory / Asthma News From Medical News Today [2009.11.18]
Be prepared, that old Boy Scout motto, is being applied with great success to operating room patients whose anatomy may make it difficult for physicians to help them breathe during surgery, Johns Hopkins researchers report in a new study. When patients undergo general anesthesia, they stop breathing on their own and anesthesiologists must quickly insert a tube into the airway as a first step in machine-assisted breathing.

New Technique For Injectable Facial Fillers Improves Comfort, Recovery
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.29]
Less pain during injections for wrinkle-fighting facial fillers. Less swelling afterward. Less time in the office waiting for anesthesia to take effect. These and other benefits of a new injection technique that UT Southwestern Medical Center plastic surgeons are helping pioneer are outlined in the October issue of Plastic and Reconstructive Surgery.

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Published Studies Related to Sufentanil (Sufentanil Epidural)

Safety and effectiveness of coadministration of intrathecal sufentanil and morphine in hyperbaric bupivacaine-based spinal anesthesia for cesarean section. [2009.07]
Subarachnoid block is a widely used technique for cesarean section... In conclusion, coadministration of sufentanil and morphine into the subarachnoid space was effective and provided longer pain relief than intrathecal sufentanil plus a single injection of subcutaneous morphine, despite a higher incidence of side effects such as nausea and vomiting.

Minimum local analgesic concentrations of ropivacaine and levobupivacaine with sufentanil for epidural analgesia in labour. [2009.07]
BACKGROUND: Sufentanil is often added to ropivacaine and levobupivacaine to provide epidural analgesia in labour. The aim of this study was to compare the analgesic potencies of epidural ropivacaine and levobupivacaine in combination with sufentanil 0.5 microg/mL, using the minimum local analgesic concentration (MLAC) model with up-down sequential allocation... CONCLUSION: When sufentanil 0.5 microg/mL was added to either ropivacaine or levobupivacaine for labour analgesia, no significant difference in analgesic potency was observed.

Epidural block for cesarean section: a comparative study between 0.5% racemic Bupivacaine (S50-R50) and 0.5% enantiomeric excess Bupivacaine (S75-R25) associated with Sufentanil. [2009.05]
BACKGROUND AND OBJECTIVES: Epidural 0.5% racemic bupivacaine associated with opioids is a technique used in cesarean sections; however, its toxicity has been questioned. 50% Enantiomeric excess bupivacaine has lower cardio- and neurotoxicity. The efficacy of epidural 0.5% racemic bupivacaine and 0.5% enantiomeric excess bupivacaine associated with sufentanil in parturients undergoing cesarean sections was evaluated... CONCLUSIONS: Epidural racemic bupivacaine and 50% enantiomeric excess bupivacaine provided adequate anesthesia for cesarean sections. 50% Enantiomeric excess bupivacaine is a promising alternative for this procedure, since it has faster regression of the motor blockade, which is desirable in obstetric patients.

Optimal dose of sufentanil in children for intubation after sevoflurane induction without neuromuscular block. [2009.05]
BACKGROUND: We studied 63 ASA I children (age 2-8 yr) to determine the sufentanil dose needed to facilitate intubation under excellent conditions after inhalation induction with various end-tidal concentrations of sevoflurane without neuromuscular block... CONCLUSIONS: Excellent intubation conditions could be obtained in children after inhalation induction with low sevoflurane concentrations and adjuvant sufentanil.

Comparison of fentanyl and sufentanil as adjuncts to bupivacaine for labor epidural analgesia. [2009.03]
STUDY OBJECTIVE: To compare the clinical efficacy of theoretically equipotent doses of fentanyl and sufentanil, each in combination with bupivacaine, for patient-controlled epidural analgesia (PCEA) for labor... CONCLUSIONS: At the assumed equipotent sufentanil to fentanyl ratio of 6:1, there is some evidence that sufentanil is clinically superior to fentanyl as an adjunct to bupivacaine in labor epidurals, although the advantages are subtle.

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Clinical Trials Related to Sufentanil (Sufentanil Epidural)

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.

A Randomized, Double-Blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain [Recruiting]
Obtaining high-quality analgesia in prehospital patients with severe pain is an important treatment objective for medical team. Opioids are recognized as the treatment of choice for relief of severe acute pain. Recommended initial analgesia of patients with severe acute pain, defined as a visual analog scale or a numerical rating scale (NRS) score of 60/100 or higher, in a prehospital setting in France consists of the administration of opioids by the medical staff of mobile intensive care units. The intravenous administration of morphine is usually considered as the gold standard for postoperative acute pain relief because of its rapid transport from the blood to target tissues after intravenous injection, its long-lasting analgesic effect without any plateau, and its well-known pharmacokinetics. Nevertheless, the short-acting opioid sufentanil might be preferable to the traditional long-acting morphine for prehospital analgesia because of its even faster onset of action and shorter duration than morphine. There is no study, to our knowledge, comparing the clinical efficacy of sufentanil vs morphine in a prehospital setting. This randomized double-blind group clinical trial is designed to determine the best intravenous opioid titration protocol by comparing sufentanil and morphine for medical prehospital treatment of adult patients with severe acute pain. Eligible patients with a numerical rating scale (NRS) score of 60/100 or higher will be randomly allocated to receive either 0. 15 µg/kg sufentanil then 0. 075 µg/kg every 3 minutes (group A) or 0. 15 mg/kg morphine then 0. 075 mg/kg every 3 minutes (group B) intravenously. The decision to provide opioid analgesia including titration of subsequent doses of narcotic is the responsibility of physicians and intravenous analgesia will be given and titrated according to the pain score every 3 minutes. The drugs will be administered by the physician from syringes of similar appearance prepared by the nurse who is not otherwise involved in the study. The protocol-defined primary outcome measure is the percentage of patients with pain relief (with a NRS score of 30/100 or lower) 15 minutes after the first injection. Secondary outcomes include pain score comparisons every 3 minutes within the first 30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment groups will do all assessments of patients. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping, awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods. Fifteen minutes after the first injection, overall patient and investigator satisfaction with analgesia was recorded.

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.

Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia [Recruiting]
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.

Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial [Recruiting]
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0. 25 microg. ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg. ml-1.

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