Diprivan (Propofol) - Summary

DIPRIVAN SUMMARY

DIPRIVAN^® (Propofol) Injectable Emulsion, USP 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 as described in the table below. 

                                      Table 3.  Indications for DIPRIVAN Injectable Emulsion

Indication	Approved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation	Adults only
Combined sedation and regional anesthesia	Adults only (see PRECAUTIONS )
Induction of General Anesthesia	Patients ≥ 3 years of age
Maintenance of General Anesthesia	Patients ≥ 2 months of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients	Adults only

Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS,   Pediatric Us e ).

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 the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses 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 Us e ).

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 propofol 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 ).

See all Diprivan indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Diprivan (Propofol)

Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. [2015]
propofol and ketamine (ketofol)... CONCLUSION: We found a similar frequency of airway and respiratory adverse events

Topical analgesia treats pain and decreases propofol use during lumbar punctures in a randomized pediatric leukemia trial. [2015]
CONCLUSIONS: This study demonstrated that the combination of EMLA cream with

Electroconvulsive therapy pre-treatment with low dose propofol: comparison with unmodified treatment. [2014]
CONCLUSION: Whilst unmodified ECT should never be used when modified ECT under

Cisatracurium pretreatment with tourniquet reduces propofol injection pain: a double-blind randomized controlled trial. [2014]
with that of lidocaine... CONCLUSIONS: 0.15 mg/kg cisatracurium effectively decreases the incidence and

Comparison of dexmedetomidine and propofol for conscious sedation in awake craniotomy: a prospective, double-blind, randomized, and controlled clinical trial. [2013]
sedation in awake craniotomy... CONCLUSIONS: Either DEX or PRO can be effectively and safely used for conscious

more studies >>

Clinical Trials Related to Diprivan (Propofol)

Comparison of Different Propofol Formulations [Completed]
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.

Neuronal Inertia in Propofol Anesthesia [Completed]
Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate, stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP) [Completed]
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking. The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.

Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation [Recruiting]
Newborns admitted to an intensive care unit often require artificial ventilation. For that purpose an endotracheal tube needs to be placed into the trachea, a procedure named endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop moving and to relax in order to enable the success of the procedure. For this sedation an anesthetic agent named propofol is often used. The used dose of propofol has not been

properly studied and as a consequence patients are under- or over - sedated and propofol

leads to side effects such as hypotension. The current study aims to find the most appropriate dose of propofol for newborns of different gestational ages and of different post-natal ages. We will use propofol in different doses and after each 5 included patients per age group we will analyze whether the dose needs to be increased or decreased. The effect of the propofol will be extensively monitored and we will study the level of sedation, the quality of intubation, the stability of the patient en the occurrence of side effects. At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.

The Effect of Different End-tidal Carbon-dioxide Levels on Cerebral CO2 Vasoreactivity and the Stiffness of Systemic Arteries During Propofol Anesthesia [Recruiting]
Purpose: The purpose of this study is to examine the effect of different carbon-dioxide concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic arteries during anesthesia with target-controlled infusion anesthesia using intravenous propofol. Propofol is a widely and commonly used intravenous anaesthetic, that is mainly used for the induction of general anesthesia and the maintenance of total intravenous anaesthesia (TIVA). Changes in the velocity of cerebral blood flow and arterial stiffness due to the different exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these parameters during the course of the narcosis. Instruments: An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of blood flow within a main artery located inside the skull. A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the radial artery, from which the stiffness of the systemic vessels can be concluded. Measurements:

- Examinations with the ultrasound and tonometry devices are carried out once before the

operation, three times during the intervention, with different exhaled CO2 values and once after the operation is completed. Hypothesis:

- Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries

during TCI anaesthesia.

more trials >>

Reports of Suspected Diprivan (Propofol) Side Effects

Anaphylactic Shock (73),  Bronchospasm (19),  Erythema (17),  Cardiac Arrest (14),  Hypotension (13),  Circulatory Collapse (12),  Bradycardia (12),  Shock (12),  Blood Pressure Decreased (11),  Tachycardia (10), more >>