Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Sufentanil

• Registration Number: NCT01777100
• Lead Sponsor: University of Sao Paulo

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sufentanil	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

Primary Outcome Measures

Name	Time	Method
Morphine consumption through patient controlled analgesia pump	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Morphine consumption through patient controlled analgesia pump	12 hours after surgery

Trial Locations

Locations (1)

Faculdade de Medicina de Botucatu; 🇧🇷 Botucatu, São Paulo, Brazil