DIPRIVAN SUMMARY
DIPRIVAN®
(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.)
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NEWS HIGHLIGHTSMedia Articles Related to Diprivan (Propofol)
Michael Jackson's Death: propofol (Diprivan) FAQ
Source: MedicineNet Tylenol Liver Damage Specialty [2009.08.26]
Title: Michael Jackson's Death: propofol (Diprivan) FAQ
Category: Doctor's Views
Created: 8/26/2009
Last Editorial Review: 8/26/2009
Propofol Plus Sedative Killed Michael Jackson
Source: MedicineNet lorazepam Specialty [2009.08.31]
Title: Propofol Plus Sedative Killed Michael Jackson
Category: Health News
Created: 8/31/2009
Last Editorial Review: 8/31/2009
Propofol Linked to Michael Jackson's Death
Source: MedicineNet lorazepam Specialty [2009.08.25]
Title: Propofol Linked to Michael Jackson's Death
Category: Health News
Created: 8/25/2009
Last Editorial Review: 8/25/2009
Published Studies Related to Diprivan (Propofol)
Does End Tidal CO(2) Monitoring During Emergency Department Procedural Sedation and Analgesia With Propofol Decrease the Incidence of Hypoxic Events? A Randomized, Controlled Trial. [2009.09.23]
STUDY OBJECTIVE: We determine whether the use of capnography is associated with a decreased incidence of hypoxic events than standard monitoring alone during emergency department (ED) sedation with propofol... CONCLUSION: In adults receiving ED propofol sedation, the addition of capnography to standard monitoring reduced hypoxia and provided advance warning for all hypoxic events.
Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. [2009.09]
BACKGROUND: Dream recall is reportedly more common after propofol than after volatile anesthesia, but this may be due to delayed emergence or more amnesia after longer-acting volatiles. The electroencephalographic signs of dreaming during anesthesia and the differences between propofol and desflurane also are unknown. The authors therefore compared dream recall after propofol- or desflurane-maintained anesthesia and analyzed electroencephalographic patterns in dreamers and nondreamers and in propofol and desflurane patients for similarities to rapid eye movement and non-rapid eye movement sleep... CONCLUSIONS: Anesthetic-related dreaming seems to occur just before awakening and is associated with a rapid eye movement-like electroencephalographic pattern.
Prevention of propofol-induced pain in children: combination of alfentanil and lidocaine vs alfentanil or lidocaine alone. [2009.09]
BACKGROUND: Pain from a propofol injection is a common side-effect in paediatric patients. This prospective, randomized, double-blind study evaluated the efficacy of a combined pretreatment of alfentanil with lidocaine on the incidence and severity of propofol injection pain in children... CONCLUSIONS: Our study demonstrated that the combination treatment of two different analgesic modalities, alfentanil and lidocaine, could prevent the moderate and severe pain on propofol injection, and reduce the incidence of mild pain compared with each drug alone.
Propofol consumption and recovery times after bispectral index or cerebral state index guidance of anaesthesia. [2009.08]
BACKGROUND: We compared the propofol requirements and recovery times when either the bispectral index (BIS) monitor or the cerebral state monitor (CSM) is used to guide propofol anaesthesia... CONCLUSIONS: Compared with BIS, propofol anaesthesia guided with CSI resulted in 20% higher propofol doses. This, however, does not lead to clinically relevant differences in recovery times.
Randomised controlled trial of patient controlled sedation for colonoscopy: Entonox versus modified patient maintained target controlled Propofol. [2009.07.03]
: Background Propofol sedation is often associated with deep sedation and decreased manoeuvrability. Patient maintained sedation has been used in such patients with minimal side-effects... There was no difference between the two groups in either depth of sedation or manoeuvrability Conclusion Both Entonox and the modified TCI Propofol provide equally effective sedation and pain relief, simultaneously allowing patients to be easily manoeuvred during the procedures.
Clinical Trials Related to Diprivan (Propofol)
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.
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.
Desflurane Versus Propofol Anesthesia for Off-Pump CABG [Completed]
The purpose of this study is to prove if anesthesia maintained with the inhaled volatile
anesthetic desflurane is superior to the intravenously applied propofol anesthesia in
off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following
parameters:
1. hemodynamic parameters during and after the operation,
2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital
stay,
3. release of heart muscle injury markers in response to surgery and intraoperative
ischaemia,
4. inflammatory response to the operation.
We suspect that insufflation anesthesia with desflurane may be superior to intravenous
anesthesia with propofol.
Propofol Concentration In The Ambient Air Of The Operating Room And In The Blood Of Anesthesia Care Providers [Active, not recruiting]
The pollution of the operating room environment by anesthetic agents had been questioned,
studied and documented in the past. These investigations demonstrated the existence of
teratogenic effects in animals and the possibility of a decrease in mental performance,
reduced fertility, fetal loss, spontaneous abortion and addictive potential in humans with
chronic exposure to trace amounts of anesthetic agents. These findings led to the
establishment of exposure limits and industry standards by consumer protection agencies, such
as National Institute for Occupational Safety and Health (NIOSH). However, these standards
applied to inhalation anesthetic agents that were excreted from the lungs of patients during
expiration. These concerns about operating room pollution weaned away with the introduction
of intravenous anesthetic agents, such as propofol, because it was believed propofol was
excreted by systems other than the lungs. Recent research points to the contrary and
demonstrates the excretion of propofol vapor in the expired gases of patients. Furthermore,
animal experiments in our laboratory establish the existence of a biological mechanism
responsible for addiction in animals exposed to trace amounts of propofol. We propose to
study the exposure levels of anesthesia care providers in the operating room, during propofol
use, under standardized conditions. Our findings will help to establish preventive measures
for propofol addiction in anesthesia care providers.
Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children [Completed]
The objective of this study is to compare intraoperative and recovery parameters in patients
who receive two different dose combinations of propofol and remifentanil in patients
undergoing a lumbar puncture.
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