Study Results
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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COMPLETED
NA
46 participants
INTERVENTIONAL
2005-10-31
2009-09-30
Brief Summary
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Detailed Description
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Patients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R, n=23). Randomization was performed using using a computer-generated randomization schedule.
Intraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone 125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was administered to to reverse neuromuscular blockade. Intraoperative monitoring included non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry, capnography and Bispectral Sedation Index (BIS®).
Postoperatively, patients remained under surveillance in the post-anesthesia care unit \[PACU\] for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min time-intervals for the first 3 hours, and every 3 hours thereafter by an independent observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.
Inflammation markers and stress hormones \[cortisol, Tumor necrosis factor (TNF-a), substance-P, melatonin and β-endorphin\] were measured in each patient before induction of anesthesia, after tracheal intubation and at the end of operation.
Statistical Analysis was performed using Kolmogorov-Smirnov test, Student's unpaired t-test or Repeated Measures ANOVA with Holm's post-hoc analysis appropriately. A p value less than 0.05 was considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Remifentanil
Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.
Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Fentanyl
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Fentanyl
Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.
Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Fentanyl
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Interventions
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Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Fentanyl
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* of category II according to the American Society of Anesthesiology (ASA) classification
* scheduled for elective dental surgery with short duration
Exclusion Criteria
* Prolonged duration of surgery (\>1 hour)
18 Years
45 Years
ALL
No
Sponsors
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Asklepieion Voulas General Hospital
OTHER_GOV
Attikon Hospital
OTHER
Responsible Party
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Paraskevi Matsota
Assoc. Prof. of Anaesthesiology
Principal Investigators
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Eirini A Sklika, Consultant
Role: PRINCIPAL_INVESTIGATOR
Asklepeion Voulas General Hospital
Locations
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2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, Greece
Countries
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Other Identifiers
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ATT968
Identifier Type: -
Identifier Source: org_study_id