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Completed

NCT Number: NCT01777100

Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

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.

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Key information

Conditions

Postoperative Pain Hyperalgesia Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18618970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil

Drug

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

Primary outcomes

  1. Morphine consumption through patient controlled analgesia pump

    Time frame: 24 hours after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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

Acronym: SAIRA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 28, 2013
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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