Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia (SAIRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fernanda Bono Fukushima, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01777100
First received: July 2, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: Sufentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Morphine consumption through patient controlled analgesia pump [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morphine consumption through patient controlled analgesia pump [ Time Frame: 15 minutes after arrival at post-anesthesia care unit ] [ Designated as safety issue: No ]
  • Morphine consumption through patient controlled analgesia pump [ Time Frame: 30 minutes after arrival at post-anesthesia care unit ] [ Designated as safety issue: No ]
  • Morphine consumption through patient controlled analgesia pump [ Time Frame: 60 minutes after arrival at post-anesthesia care unit ] [ Designated as safety issue: No ]
  • Morphine consumption through patient controlled analgesia pump [ Time Frame: 12 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Fernanda Bono Fukushima, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01777100     History of Changes
Other Study ID Numbers: UNESP
Study First Received: July 2, 2012
Last Updated: January 23, 2013
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014