Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-01-31

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sufentanil

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

Intervention Type DRUG

Other Intervention Names

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No