SUFENTANIL SUMMARY
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
Published Studies Related to Sufentanil (Sufentanil Epidural)
A dose-finding study of sufentanil sublingual microtablets for the management of
postoperative bunionectomy pain. [2014]
less frequent administration and avoid the setup of a drug delivery system... CONCLUSION: The SSM 30 µg may be an effective, noninvasive alternative to health
The effect of sufentanil administration on remifentanil-based anaesthesia during
laparoscopic gynaecological surgery: a double-blind randomized controlled trial. [2014]
This study assessed the effect of sufentanil administered before conclusion of
remifentanil-based anaesthesia on postoperative hyperalgesia and haemodynamic
stability in patients undergoing laparoscopic gynaecological surgery. The
patients were randomly allocated to a sufentanil administration group (S group)
or a normal saline administration group (C group)...
Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the
management of postoperative pain. [2013]
postoperative pain management... CONCLUSIONS: Sufentanil formulated as a sublingual solid dosage form provides a
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.
Clinical Trials Related to Sufentanil (Sufentanil Epidural)
Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System [Recruiting]
Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant [Recruiting]
The main objective is the comparison of intubation conditions after anesthetic induction
bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients
undergoing surgery for tooth extraction.
Intubation without myorelaxant with propofol and sufentanil is classic but less efficient
than induction with curare on achieving perfect intubation conditions. The use of a protocol
without curare is sometimes justified for short gestures or when you want to avoid allergia.
Remifentanil often provides excellent intubation conditions without myorelaxant. However,
remifentanil was never compared to sufentanil in terms of intubating conditions without
muscle relaxant.
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children [Completed]
Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil [Recruiting]
Induction of general anaesthesia with a combination of opiates and hypnotics often induces
vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure
(MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize
tissue oxygenation, particularly cerebral oxygenation. Previous research of the
investigators group has revealed that atropine has an exceptionally beneficial effect on the
determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators
have demonstrated a significant and clinically relevant increase in CO and cerebral tissue
oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more
usual clinical practice of administrating classical vasoactive medication such as
phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and
SctO2. In previous research the investigators used standardized target controlled
propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known
that remifentanil has more intense haemodynamic side-effects compared to other opiates such
as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial
effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally
valid during anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep
general anaesthesia, which is usually performed with the combination of drugs as mentioned
above. Because these patients often experience severe haemodynamic fluctuations they need to
be closely monitored.
Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 Mcg for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery [Completed]
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