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Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia (SAIRA)

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ClinicalTrials.gov Identifier: NCT01777100
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Fernanda Bono Fukushima, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Sufentanil Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: 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
Drug: Sufentanil
Sufentanil 0.5 mcg.kg-1 at anesthesia induction (single dose)
Other Names:
  • CAS number 56030-54-7
  • ATC code N01AH03
  • PubChem CID 41693
  • DrugBank DB00708
  • ChemSpider 38043
  • UNII AFE2YW0IIZ
  • KEGG D05938 Yes
  • ChEBI CHEBI:9316
  • ChEMBL CHEMBL658
  • Formula C22H30N2O2S

No Intervention: remifentanil
Anesthetic induction with target-controlled infusion IV remifentanil at 0.5 mcg.kg-1.min-1 in 5 minutes followed by analgesic maintenance on demand of IV target-controlled infusion remifentanil at 0.1 to 0.3 mcg.kg-1.min-1.



Primary Outcome Measures :
  1. Morphine consumption through patient controlled analgesia pump [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Morphine consumption through patient controlled analgesia pump [ Time Frame: 15 minutes after arrival at post-anesthesia care unit ]
  2. Morphine consumption through patient controlled analgesia pump [ Time Frame: 30 minutes after arrival at post-anesthesia care unit ]
  3. Morphine consumption through patient controlled analgesia pump [ Time Frame: 60 minutes after arrival at post-anesthesia care unit ]
  4. Morphine consumption through patient controlled analgesia pump [ Time Frame: 12 hours after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777100


Locations
Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil, 18618970
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fernanda B Fukushima, MD PhD UPECLIN HC FM Botucatu Unesp

Responsible Party: Fernanda Bono Fukushima, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01777100     History of Changes
Other Study ID Numbers: UNESP
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Fernanda Bono Fukushima, University of Sao Paulo:
Postoperative pain
Patient controlled analgesia
Hyperalgesia
Remifentanil
Sufentanil
Morphine
Abdominal surgery
Safety

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Remifentanil
Sufentanil
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia