SAIRA: Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01777100

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Sufentanil	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Sufentanil Sufentanil 0.5 mcg.kg-1 at anesthesia induction (single dose) Other Names: 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
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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

Drug: Sufentanil

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

Other Names:

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Morphine consumption through patient controlled analgesia pump [24 hours after surgery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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