Clinical trial NCT01777100: Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative pain
Patient controlled analgesia
Hyperalgesia
Remifentanil
Sufentanil
Morphine
Abdominal surgery
Safety
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption through patient controlled analgesia pump
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Morphine consumption through patient controlled analgesia pump
timeFrame: 15 minutes after arrival at post-anesthesia care unit
measure: Morphine consumption through patient controlled analgesia pump
timeFrame: 30 minutes after arrival at post-anesthesia care unit
measure: Morphine consumption through patient controlled analgesia pump
timeFrame: 60 minutes after arrival at post-anesthesia care unit
measure: Morphine consumption through patient controlled analgesia pump
timeFrame: 12 hours after surgery
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu
state: São Paulo
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Fernanda B Fukushima, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: