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Clinical Trials/NCT01777100
NCT01777100
Completed
Phase 4

Phase IV Study of Postoperative Analgesic Efficacy and Safety of Anesthesia Induction With Single Dose Sufentanil for Open Abdominal Surgery Under Continuous Remifentanil Anesthesia Versus Total Intravenous Remifentanil Anesthesia

University of Sao Paulo1 site in 1 country40 target enrollmentJuly 2012
InterventionsSufentanil

Overview

Phase
Phase 4
Intervention
Sufentanil
Conditions
Postoperative Pain
Sponsor
University of Sao Paulo
Enrollment
40
Locations
1
Primary Endpoint
Morphine consumption through patient controlled analgesia pump
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The appropriate management of postoperative pain is recognized as an important clinical challenge with implications beyond humanitarian issues. Evidence shows that effective postoperative analgesia is associated with physiological benefits to the patient, shortened length of hospital stay and lower rates of in-hospital complications, such as pneumonia, delirium and persistent pain after surgery. However, despite the availability of several analgesic drugs and strategies the prevention and treatment of postoperative pain is often suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous infusion for anesthesia for several surgical procedures. Remifentanil has been extensively advocated as a means to provide quick patient awakening in the immediate postoperative period with a very low risk of respiratory depression. Yet it does not provide residual analgesia and postoperative pain is a major concern. In order to overcome this limitation, practicing anesthesiologists frequently give patients a single dose of Sufentanil, a long acting opioid, during the induction of anesthesia where Remifentanil will be used in continuous infusion. However the effectiveness of this strategy still lacks evidence from controlled clinical trials.

Detailed Description

We propose the current randomized clinical trial to assess the analgesic effectiveness of Sufentanil administered as a single dose during the induction of anesthesia for the management of postoperative pain in patients undergoing open abdominal surgery performed with continuous infusion of Remifentanil.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernanda Bono Fukushima

MD, PhD

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Physical status (American Society of Anesthesiologists) 1, 2 or 3
  • Age 18 years and older
  • Patients selected for open Abdominal surgery under general total intravenous anesthesia

Exclusion Criteria

  • Physical status (American Society of Anesthesiologists) 4
  • Patients undergoing other anesthesia technic (subarachnoid, epidural, nerve block, etc)
  • History of anaphylactic reaction after use of tramadol, dipyrone, propofol, rocuronium, dexamethasone, sufentanil, remifentanil or morphine
  • Chronic uso of drugs that are associated with major increases in the activity of P450 isozymes (Carbamazepine, phenobarbital, rifampin, tobacco, phenytoin, Hypericum perforatum)
  • Previous History of Drug addiction
  • alcoholism

Arms & Interventions

sufentanil

Anesthetic induction with IV sufentanil at 0.5 mcg.kg-1 and analgesic maintenance with IV remifentanil at 0.1 to 0.3 mcg.kg-1.min-1 on demand target-controlled infusion

Intervention: Sufentanil

Outcomes

Primary Outcomes

Morphine consumption through patient controlled analgesia pump

Time Frame: 24 hours after surgery

Secondary Outcomes

  • Morphine consumption through patient controlled analgesia pump(12 hours after surgery)

Study Sites (1)

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