Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sufentanil<br>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<br>* Sufentanil 0.5 mcg.kg-1 at anesthesia induction (single dose)<br>* Other names: Formula C22H30N2O2S;|
| No Intervention: remifentanil<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Patient controlled analgesia, Hyperalgesia, Remifentanil, Sufentanil, Morphine, Abdominal surgery, Safety