Propofol: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Propofol appears in the FDA drug-label database. Marketed as propofol.
- Drug class
- General Anesthetic (FDA established pharmacologic class)
FDA-approved use
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients Sedation for Adult Patients in Combination with Regional Anesthesia Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use Propofol 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 [see Pediatric Use ( 8.4 )] . Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4 )]. Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use ( 8.4 )].…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-05-25 |
| Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-04-08 |
| Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution. — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-12-12 |
| Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-08-14 |
| Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2014-10-06 |
Phase breakdown
Conditions being studied
Recruiting trials involving Propofol
- A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
- Anesthesia and Non-small Cell Lung Cancer Recurrence
- Antidepressant Response of DMT Masked With Propofol
- Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
- Effect of Remimazolam and Propofol on Postoperative Delirium
- Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery in Video-Assisted Thoracoscopic Surgery
- Effects of Propofol on Brain Function in Patients With Parkinson's Disease
- Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
- Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine
- Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
- Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery
- Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
- The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
- The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action
- The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
Common questions
Is Propofol FDA-approved?
Yes, marketed as propofol.
How many recruiting trials involve Propofol?
15 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.