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| Name | Class |
|---|---|
| Asklepieion Voulas General Hospital | OTHER_GOV |
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This study was a prospective comparative study. The purpose of this study was to investigate the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary aims were to investigate comparatively their effect on patients intraoperative hemodynamic response and postoperative analgesia.
The study included 46 adult patients with cognitive impairment who underwent day-case dental surgery under general anesthesia with propofol aiming to keep a BIS-values range between 40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if needed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Active Comparator | Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h. |
|
| Fentanyl | Active Comparator | Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline plasma cortisol values at 1 hour | Plasma cortisol values were measured with an ELISA kit as mg/dl | At 1 hour after the induction of anesthesia and surgery |
| Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour | Tumor necrosis factor-α (TNF-α) measurement was performed with Elisa immunoenzyme assay as pg/ml | At 1 hour after the induction of anesthesia and surgery |
| Change from baseline plasma substance-P values at 1 hour | Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml | At 1 hour after the induction of anesthesia and surgery |
| Change from baseline plasma melatonin values at 1 hour | Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml | At 1 hour after the induction of anesthesia and surgery |
| Change from baseline plasma β-endorphin values at 1 hour | β-endorphin was measured with Elisa immunoenzyme assay as ng/ml | At 1 hour after the induction of anesthesia and surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups | Measurements before the induction of anesthesia (baseline values) and at and 60 min (1 hour) after the induction of anesthesia | 1 hour |
| Differences in intraoperative heart rate values (bmp) between the two study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eirini A Sklika, Consultant | Asklepeion Voulas General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Anesthesiology, Attikon University Hospital | Athens | Attica | 12462 | Greece |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Fentanyl | Drug | Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery. |
|
|
Measurements before the induction of anesthesia (baseline values) and at 60 min (1 hour) after the induction of anesthesia |
| 1 hour |
| Differences in postoperative pain scores scores between the two study groups | Pain was assessed using the Wong-Baker faces pain rating scale (0-6) at 12 postoperative hours | Up to 12 postoperative hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |