Postoperative Pain Clinical Trial
— REFEDSOfficial title:
Remifentanil vs Fentanyl During Day Case Dental Surgery in Persons With Special Needs: a Comparative Study of Their Effect on Stress Response and Postoperative Pain
Verified date | November 2015 |
Source | Attikon Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | September 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Patients with cognitive impairment - of category II according to the American Society of Anesthesiology (ASA) classification - scheduled for elective dental surgery with short duration Exclusion Criteria: - Patients of more than category II of American Society of Anesthesiology (ASA) classification - Prolonged duration of surgery (>1 hour) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Department of Anesthesiology, Attikon University Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Attikon Hospital | Asklepieion Voulas General Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Change from baseline plasma tumor necrosis factor-a (TNF-a) values at 1 hour | Tumor necrosis factor-a (TNF-a) measurement was performed with Elisa immunoenzyme assay as pg/ml | At 1 hour after the induction of anesthesia and surgery | No |
Primary | 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 | No |
Primary | 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 | No |
Primary | Change from baseline plasma ß-endorphin values at 1 hour | ß-endorphin was measured with Elisa immunoenzyme assay as ng/ml | At 1 hour after the induction of anesthesia and surgery | No |
Secondary | 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 | No |
Secondary | Differences in intraoperative heart rate values (bmp) between the two study groups | Measurements before the induction of anesthesia (baseline values) and at 60 min (1 hour) after the induction of anesthesia | 1 hour | No |
Secondary | 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 | No |
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