Remifentanil and Fentanyl in Dental Surgery (REFEDS)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Remifentanil Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h. |
Drug: Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Other Names:
Drug: Fentanyl
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Other Names:
|
| Active Comparator: Fentanyl Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia. |
Drug: Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Other Names:
Drug: Fentanyl
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline plasma cortisol values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
Plasma cortisol values were measured with an ELISA kit as mg/dl
- Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
Tumor necrosis factor-α (TNF-α) measurement was performed with Elisa immunoenzyme assay as pg/ml
- Change from baseline plasma substance-P values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml
- Change from baseline plasma melatonin values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml
- Change from baseline plasma β-endorphin values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
β-endorphin was measured with Elisa immunoenzyme assay as ng/ml
Secondary Outcome Measures
- Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups [1 hour]
Measurements before the induction of anesthesia (baseline values) and at and 60 min (1 hour) after the induction of anesthesia
- Differences in intraoperative heart rate values (bmp) between the two study groups [1 hour]
Measurements before the induction of anesthesia (baseline values) and at 60 min (1 hour) after the induction of anesthesia
- Differences in postoperative pain scores scores between the two study groups [Up to 12 postoperative hours]
Pain was assessed using the Wong-Baker faces pain rating scale (0-6) at 12 postoperative hours
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Department of Anesthesiology, Attikon University Hospital | Athens | Attiki | Greece | 12462 |
Sponsors and Collaborators
- Attikon Hospital
- Asklepieion Voulas General Hospital
Investigators
- Principal Investigator: Eirini A Sklika, Consultant, Asklepeion Voulas General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATT968