Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Postoperative Pain Clinical Trial

— SAIRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777100
• Other study ID #: UNESP
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2012
• Last updated: May 26, 2015
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu	Botucatu	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption through patient controlled analgesia pump		24 hours after surgery	No
Secondary	Morphine consumption through patient controlled analgesia pump		15 minutes after arrival at post-anesthesia care unit	No
Secondary	Morphine consumption through patient controlled analgesia pump		30 minutes after arrival at post-anesthesia care unit	No
Secondary	Morphine consumption through patient controlled analgesia pump		60 minutes after arrival at post-anesthesia care unit	No
Secondary	Morphine consumption through patient controlled analgesia pump		12 hours after surgery	No