Sufentanil

Introduction

Sufentanil (sufentanil citrate) has been marketed in China since 2003. It has greater analgesic potency and a superior safety profile as compared to other fentanil derivatives. Sufentanil is indicated for: Anesthesia during procedures including endotracheal intubation for artificial respiration. As an analgesic component of combination anesthesia. For the induction and maintenance of general anesthesia in major operations.

Efficacy

Analgesic Effect - Sufentanil has a better dose-effective relationship than other fentanil derivatives

Pain Threshold Current - Sufentanil produces statistically greater and longer-lasting increases in pain threshold current than fentanyl

Source : Bailey P et al, ANESTH ANALG 1990;70:8-15

Hypnotic Effect – Thiopenthal requirements are less for Sufentanil than for Fentanyl for induction of sleep.

Source: Anesthesiology 1989; 70:26-30

Safety

Continuous Infusion – Sufentanil does not accumulate in the tissues.

Sources: Anesthesiology (1991) Jan; 74(1):53-63
Glass PSA, Pharmacology of remifentanil. European Journal of Anaesthesiology, 1995, 12(Suppl. 10):73-74

Ventilatory Depression – Sufentanil has low impact on circulatory system, producing less ventilatory depression than Fentanyl.

Source : Bailey PL, Streisand JB, East KA, et al. Differences in magnitude and duration of opioid-induced respiratory depression and analgesia with fentanyl and sufentanil. Anesth Analg 1990; 70:8-15.

Nausea and Vomiting – Sufentanil induces less severe nausea and vomiting, while producing superior analgesic effects as compared to Fentanyl

Source: Yao Tong, Wu Xin-Min, Yang Shun-Wei. Postoperative PCEA with Sufentanil plus ropivacaine. Chinese Journal of Pain Medicine 2005, 11, (3)

Extrahepatic Metabolism – Total and hepatic clearance significantly higher in patients administered Sufentanil for orthotopic liver transplantation (OLT)

Source: Marc Raucoules, Michel Kaidomar, et al., Hepatic disposition of alfentanil and sufentanil in patients undergoing orthotopic liver transplantation. Anesth Analg 1997; 84:1019-24

Prescribing Information

Guidelines for Clinical Use

• Balanced anesthesia

Induction of Anesthesia: Loading doses: 0.25-2 µg/kg Maintenance of Anesthesia:   Additional boli: 0.03-0.15 µg/kg   Infusion rate: 0.2-1.5 µg/kg/h Note: Effective plasma concentrations 0.5-3ng/ml,   Threshold plasma concentration for ventilation < 0.2ng/ml   Infusion should be stoped 45 min before the end of surgery   No bolus administration within 45 min before extubation

• Total intravenous anesthesia (TIVA/TCI) – Combination of propofol and sufentanil; Extubation immediately after surgery

Induction of Anesthesia: Sufentanil-TCI: Cp=2ng/ml—› Ce=0.3ng/ml—› Cp=0.5ng/ml. Propofol-TCI: Cp=3-5ug/ml,"LOC", Rocuronium: 0.6mg/kg 2min later Intubation Before cutting bark: Sufentanil: Cp=0.5ng/ml Propofol: Cp=3-5ug/ml Loading doses: 0.25-2 µg/kg Maintenance of Anesthesia:   TCI-TIVA Sufentanil: Cp=0.2-0.5ng/ml; Propofol:Cp=3-5ug/ml.

Source : Combination of Propofol and Sufentanil TCI for total intravenous anesthesia. Beijing Chao-Yang Hospital, Wu Qiwei, Yue Yun.

• Postoperative Analgesia

Patient Controlled Intravenous Analgesia (PCIA)

Loading dose : 5μg (infusion after extubation) loading dose Compatibility drug : Sufentanil 150μg+0.9%NS to 200ml Background dose : 3ml/h  Single dose : 2ml Lockout time : 30min

Source: Administration doses from Southern Hospital

Patient Controlled Epidural Analgesia (PCEA)

Frequenty Asked Questions

Q: Are there any restrictions associated with administering Sufentanil to patients involved in competitive athletics?
A: Sufentanil may be restricted in certain sports, as it is considered to be a member of a prohibited group (Fentanil derivatives). Athletes should consult with the appropriate sports authorities.

Q: What are the possible adverse effects of Sufentanil?
A: As an opioid analgesic related to fentanil, it has the side effects of opioid analgesics in general, including respiratory depression, nausea and vomiting thoracic muscle rigidity, decrease in blood pressure, bradycardia, tachycardia, etc.

Q: How many administration routes are there for Sufentanil?
A: Sufentanil may be administered epidurally, intrathecally, or transdermally.[1,2]

[1] Ionescu TI, et al. Pharmacokinetic study of extradural and intrathecal sufentanil anaesthesia for major surgery. Br. J Anaesth 1991; 66: 458-64
[2] Sebel PS, et al. Transdermal absorption of fentanyl and sufentanil in man, Eur J Clin Pharmacol 1987; 32:529-31.

History of Sufentanil in China

• In March 2002, clinical trials for registration in China were completed. (Collaborators: Beijing PUMC Hospital, Peking University First Hospital, Beijing Chao-Yang Hospital). Sufentanil was launched the following year in 2003, and was included in national medical insurance in 2004.

• From 2004 through 2006, national multicenter clinical studies regarding the use of Sufentanil in cardiovascular surgery and labor analgesia were completed. With over 3,000 cases studied during this period, the safety and efficacy of Sufentanil were well established.

• Between 2004 and 2007, more than 600 articles related to Sufentanil were published in a wide range of journals and magazines. These included over 80 articles published in The Chinese Journal of Anesthesiology, the most respected Chinese journal on anesthesia and analgesia.

• During 2005-2007, PUMC Pharmaceutical, in cooperation with the editorial board of The Chinese Journal of Anesthesiology, successfully sponsored two national paper competitions regarding clinical applications of Sufentanil. Roughly 200 articles were submitted, 42 of which were subsequently published in Chinese Journal of Anesthesiology. Ceremonies for the 2006 and 2007 First Prize winners were held in Qingdao and Beijing, respectively.

• In July 2008, collected papers from the above competitions were published by PUMC Pharmaceutical, with an introduction written by Professor Luo Ailun, a leading anesthesiologist and editor-in-chief of The Chinese Journal of Anesthesiology.