Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia (SAIRA)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Sufentanil

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
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618970
      • Faculdade de Medicina de Botucatu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption through patient controlled analgesia pump	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Fernanda B Fukushima, MD PhD, UPECLIN HC FM Botucatu Unesp

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (ESTIMATE): January 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Remifentanil; Safety; Morphine; Sufentanil; Postoperative pain; Patient controlled analgesia; Hyperalgesia; Abdominal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: Unesp