ULTIVA SUMMARY
ULTIVA (remifentanil hydrochloride) for Injection is a µ-opioid agonist chemically designated as a 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt, C20H28N2O5•HCl, with a molecular weight of 412.
ULTIVA is indicated for IV administration:
- As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
- For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
- As an analgesic component of monitored anesthesia care in adult patients.
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NEWS HIGHLIGHTS
Published Studies Related to Ultiva (Remifentanil)
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)...
Total intravenous anesthesia using remifentanil in extracorporeal shock wave
lithotripsy (ESWL). Comparison of two dosages: a randomized clinical trial. [2014]
to assess which is the most appropriate infusion rate... CONCLUSION: According with previous results remifentanil at the infusion rate of
Remifentanil during cardiac surgery is associated with chronic thoracic pain 1 yr
after sternotomy. [2012]
patient and perioperative characteristics... CONCLUSIONS: In this follow-up study in cardiac surgery patients, intraoperative
An intraoperative small dose of ketamine prevents remifentanil-induced postanesthetic shivering. [2011.09]
Patients undergoing gynecological laparotomy were randomized to receive either 0.5 mg/kg ketamine at induction of anesthesia followed by an infusion of 0.3 mg/kg/h until the end of surgery (ketamine group, n = 32), or an equivalent volume of normal saline (control group, n = 32)...
A double-blind randomised comparison of intravenous patient-controlled remifentanil with intramuscular pethidine for labour analgesia. [2011.09]
In a prospective, double-blind, randomised controlled trial, we compared the efficacy of patient-controlled analgesia using remifentanil (25-30 mug per bolus) with intramuscular pethidine (50-75 mg) for labour analgesia in 69 parturients. Parturients receiving patient-controlled analgesia reported less pain than those receiving intramuscular pethidine throughout the study period (p < 0.001), with maximal reduction in visual analogue pain score at 2 h after commencement of analgesia (mean (SD) 20 (17) in the patient-controlled analgesia group and 36 (22) in the intramuscular pethidine group...
Clinical Trials Related to Ultiva (Remifentanil)
Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy [Completed]
Modulation of Remifentanil-induced Postinfusion Hyperalgesia [Completed]
In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This
problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid
induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has
been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model. Both
COX-1 and COX-2 are expressed in the spinal cord. It would be of interest to investigate
whether a COX-1 preferring inhibitor like ketorolac also can reduce opioid induced
hyperalgesic in this experimental pain model.
Pharmacogenetics of Remifentanil in Patients With Hypertension Undergoing Cesarean Delivery Under General Anesthesia [Completed]
Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of
insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the
lack of opioid administration. Opioids easily cross placental barrier and negatively
influence newborn postpartum adaptation by respiratory depression. Introduction to GA is
thus accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia.
The use of ultra-short acting opioid remifentanil should suppress stress response in mother
without increasing the risk for newborn. There are only a few clinical data available. This
study will be the first one systematically studying the influence of remifentanil in
pregnant women with hypertension on hemodynamic stability and newborns safety. This study
will also identify potential pharmacogenetic factors of individual variability in
remifentanil response with respect of drug efficacy and safety in mother and newborn.
Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery [Recruiting]
Optimal Sevoflurane Concentration for Intubation in Combination of Clincal Remifentanil Doses [Recruiting]
Intubation is a procedure that requires well relaxed muscles while general anesthesia is
performed. In order to get adequate muscle relaxation, remifentanil, sevoflurane or both
agents in combination have been reported as they can provide adequate conditions for
laryngoscopy and tracheal intubation without using muscle relaxants.
However, there were no previous studies to find the effective dose of sevoflurane in
combination with different bolus doses of remifentanil to obtain adequate endotracheal
intubation conditions without using muscle relaxants. The aim of this study is to
investigate the change in the minimum sevoflurane alveolar concentration which produces an
adequate endotracheal intubation condition when sevoflurane is combined with different bolus
doses of remifentanil used in clinical practice.
Reports of Suspected Ultiva (Remifentanil) Side Effects
Drug Rash With Eosinophilia and Systemic Symptoms (21),
Premature Baby (11),
Drug Withdrawal Syndrome Neonatal (8),
Transient Tachypnoea of THE Newborn (8),
Vomiting (8),
Hyperreflexia (8),
Irritability (8),
Feeding Disorder (8),
Anaphylactic Shock (7),
OFF Label USE (7), more >>
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