Overview

Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.

Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Ibuprofen
Criteria
Inclusion Criteria:

1. Adults, 18 and over, who will undergo surgery lasting longer than one hour with
general anesthesia

2. Subject is non-lactating and is either:

- Not of childbearing potential

- Of childbearing potential but is not pregnant at time of baseline as determined
by pre-surgical pregnancy testing.

3. Subject is ASA physical status 1, 2, or 3

Exclusion Criteria:

1. Cognitively impaired (by history)

2. Subject requires chronic antipsychotic history

3. Subject is anticipated to require an additional surgery within 90 days after the
intended surgery

4. Chronic use of steroids or opioids

5. Subject has received treatment with COX inhibitors within 3 days of study entry

6. Subject for whom opiates, benzodiazepines, and COX inhibitors are contraindicated