(propofol) Injectable Emulsion
FOR IV ADMINISTRATION
DIPRIVAN® (propofol) Injectable Emulsion is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration.
DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used for both induction and/or maintenance of anesthesia as part of a balanced anesthetic technique for inpatient and outpatient surgery in adult patients and pediatric patients greater than 3 years of age. DIPRIVAN Injectable Emulsion can also be used for maintenance of anesthesia as part of a balanced anesthetic technique for inpatient and outpatient surgery in adult patients and in pediatric patients greater than 2 months of age. DIPRIVAN Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In adult patients, DIPRIVAN Injectable Emulsion, when administered intravenously as directed, can be used to initiate and maintain monitored anesthesia care (MAC) sedation during diagnostic procedures. DIPRIVAN Injectable Emulsion may also be used for MAC sedation in conjunction with local/regional anesthesia in patients undergoing surgical procedures. (See PRECAUTIONS.)
Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion have not been established for MAC Sedation/light general anesthesia in the pediatric population undergoing diagnostic or nonsurgical procedures and therefore it is not recommended for this use. (See PRECAUTIONS, Pediatric Use).
DIPRIVAN Injectable Emulsion should only be administered to intubated, mechanically ventilated adult patients in the Intensive Care Unit (ICU) to provide continuous sedation and control of stress responses. In this setting, DIPRIVAN Injectable Emulsion should be administered only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
DIPRIVAN Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established. (See PRECAUTIONS, Pediatric Use).
DIPRIVAN Injectable Emulsion is not recommended for obstetrics, including cesarean section deliveries. DIPRIVAN Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN Injectable Emulsion may be associated with neonatal depression. (See PRECAUTIONS.)
DIPRIVAN Injectable Emulsion is not recommended for use in nursing mothers because DIPRIVAN Injectable Emulsion has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known. (See PRECAUTIONS.)
Published Studies Related to Diprivan (Propofol)
Ketofol (mixture of ketamine and propofol) administration in electroconvulsive
The aim of this study was to evaluate the effect of a ketamine:propofol
combination ('ketofol') for electroconvulsive therapy on seizure activity,
haemodynamic response and recovery parameters, and to compare with these with the
effects of propofol alone...
Dental sedation for patients with intellectual disability: a prospective study of manual control versus Bispectral Index-guided target-controlled infusion of propofol. [2011.12]
STUDY OBJECTIVE: To investigate the use of propofol sedation using Bispectral Index (BIS)-guided target-controlled infusion (TCI) in dental patients with intellectual disability... CONCLUSION: Propofol sedation using BIS-guided TCI is a useful and safe method in the management of patients with intellectual disability. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. [2011.12]
BACKGROUND: In patients undergoing routine upper EGD, propofol is increasingly used without pharyngeal anesthesia because of its excellent sedative properties. It is unclear whether this practice is non-inferior in regard to ease of endoscopic intubation and patient comfort. OBJECTIVE: To assess the relevance of local pharyngeal anesthesia regarding the ease of EGD performance in patients sedated with propofol as monotherapy... CONCLUSION: Topical pharyngeal anesthesia reduces the gag reflex in patients sedated with propofol even though it does not seem to have an influence on the ease of the procedure and on patient or endoscopist satisfaction in adequately sedated patients. (Clinical trial registration number: NCT01081002.). Copyright (c) 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
Protection by remote ischemic preconditioning during coronary artery bypass graft surgery with isoflurane but not propofol - a clinical trial. [2011.11.21]
BACKGROUND: Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown. We tested whether RIPC is associated with differential effects depending on background anesthesia. Specifically, we hypothesized that RIPC during isoflurane anesthesia attenuates myocardial injury in patients undergoing coronary artery bypass graft (CABG) surgery, and that effects may be different during propofol anesthesia... CONCLUSION: Thus, RIPC during isoflurane but not during propofol anesthesia decreased myocardial damage in patients undergoing CABG surgery. Accordingly, effects of RIPC evoked by upper limb ischemia/reperfusion depend on background anesthesia, with combined RIPC/isoflurane exerting greater beneficial effects under conditions studied. (c) 2011 The Authors Acta Anaesthesiologica Scandinavica (c) 2011 The Acta Anaesthesiologica Scandinavica Foundation.
The utility of high-flow oxygen during emergency department procedural sedation and analgesia with propofol: a randomized, controlled trial. [2011.10]
STUDY OBJECTIVE: We determine whether high-flow oxygen reduces the incidence of hypoxia by 20% in adults receiving propofol for emergency department (ED) sedation compared with room air... CONCLUSION: High-flow oxygen reduces the frequency of hypoxia during ED propofol sedation in adults. Copyright (c) 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.
Clinical Trials Related to Diprivan (Propofol)
Comparison of Different Propofol Formulations [Recruiting]
The objective of this study is to evaluate the influence of different propofol
formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with
lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index
target of 50.
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma [Completed]
The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in
children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation
alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better
sedation induction, recovery profile and is preferred by patients/families. The study is a
double blind, randomized, placebo controlled crossover study. Following the induction phase
of chemotherapy, children will be randomized in a crossover manner to receive either
fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied
on two separate occasions, once with propofol-placebo (normal saline) and once with
propofol-fentanyl. Children will be monitored continuously by pulse oximetry,
electrocardiogram (ECG) and direct nursing and physician observation during the sedation in
accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol
will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7
for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be
recorded every 3 minutes by a study investigator during sedation.
Compare Pharmaco-economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia [Not yet recruiting]
This study is performed to demonstrate that the direct anesthetic costs of a low fresh gas
flow balanced sevoflurane anesthesia for elective laparoscopy are less compared to the
direct anesthetic costs of a target-controlled infusion anesthesia based on propofol.
A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters [Recruiting]
This is a pilot study to compare the hemodynamic changes that occur during induction with a
novel drug combination known as ketofol (propofol and ketamine admixture with that of
propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely
used as induction agents and their effects on patient hemodynamics are well known. Some of
these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on
patient hemodynamics. We seek to investigate the hemodynamic changes associated with a
novel drug combination known as ketofol (ketamine/propofol admixture) during induction and
compare them to propofol. If we determine that the changes produced by ketofol are
favorable compared with propofol, we then will seek to test its use in the trauma setting in
a subsequent randomized controlled trial.
COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations [Suspended]
The aim of the study is to prove if general anesthesia with inhaled sevoflurane reduces the
frequency of neurological and cognitive impairment after open-heart operations with use of
cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.
Reports of Suspected Diprivan (Propofol) Side Effects
Anaphylactic Shock (73),
Cardiac Arrest (14),
Circulatory Collapse (12),
Blood Pressure Decreased (11),
Tachycardia (10), more >>
Page last updated: 2013-02-10