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

NCT01377441 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 11-01188
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Inflammatory Response

Keywords

Ibuprofen; Cytokines; Recovery; IV ibuprofen; major surgery

Outcome Measures

Primary Outcomes (1)

• Concentrations of the Cytokines Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and Interferon-gamma (IFN-gamma) as Well as Prostaglandin E2 at Different Time Points.

  Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.

  48h

Secondary Outcomes (1)

• Quality of Recovery Score (QoR-40).

  48h

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.

Drug: Ibuprofen

Placebo/Saline solution

PLACEBO COMPARATOR

Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo

Drug: Placebo/Saline solution

Interventions

Ibuprofen DRUG

Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose.

Also known as: nonsteroidal anti-inflammatory drug (NSAID)

Ibuprofen

Placebo/Saline solution DRUG

Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Placebo/Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18 and over, who will undergo surgery lasting longer than one hour with general anesthesia
• 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.
• Subject is ASA physical status 1, 2, or 3

You may not qualify if:

• Cognitively impaired (by history)
• Subject requires chronic antipsychotic history
• Subject is anticipated to require an additional surgery within 90 days after the intended surgery
• Chronic use of steroids or opioids
• Subject has received treatment with COX inhibitors within 3 days of study entry
• Subject for whom opiates, benzodiazepines, and COX inhibitors are contraindicated

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NY Methodist Hospital

Brooklyn, New York, 11215, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Saline Solution

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Lisa Doan, MD
• Organization: NYU School of Medicine

lisa.doan@nyumc.org

212.263.5072

Study Officials

• Lisa Doan, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 22, 2017
• Results First Posted: December 22, 2014

Record last verified: 2017-11

Locations

US (2)