Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

NCT01777100 | Completed Phase 4

• 1 other identifier: UNESP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Patient controlled analgesia; Hyperalgesia; Remifentanil; Sufentanil; Morphine; Abdominal surgery; Safety

Outcome Measures

Primary Outcomes (1)

• Morphine consumption through patient controlled analgesia pump

  24 hours after surgery

Secondary Outcomes (4)

• Morphine consumption through patient controlled analgesia pump

  15 minutes after arrival at post-anesthesia care unit

• Morphine consumption through patient controlled analgesia pump

  30 minutes after arrival at post-anesthesia care unit

• Morphine consumption through patient controlled analgesia pump

  60 minutes after arrival at post-anesthesia care unit

• Morphine consumption through patient controlled analgesia pump

  12 hours after surgery

Study Arms (2)

sufentanil

EXPERIMENTAL

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

remifentanil

NO INTERVENTION

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.

Interventions

Sufentanil DRUG

Sufentanil 0.5 mcg.kg-1 at anesthesia induction (single dose)

Also known as: 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

sufentanil

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18618970, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fernanda B Fukushima, MD PhD

  UPECLIN HC FM Botucatu Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: January 28, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

BR (1)