Clinical trial NCT02619032: Remifentanil and Fentanyl in Dental Surgery (REFEDS)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: remifentanil
fentanyl
dental surgery
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: Asklepieion Voulas General Hospital
First posted: 2015-12-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change from baseline plasma cortisol values at 1 hour
timeFrame: At 1 hour after the induction of anesthesia and surgery
measure: Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour
timeFrame: At 1 hour after the induction of anesthesia and surgery
measure: Change from baseline plasma substance-P values at 1 hour
timeFrame: At 1 hour after the induction of anesthesia and surgery
measure: Change from baseline plasma melatonin values at 1 hour
timeFrame: At 1 hour after the induction of anesthesia and surgery
measure: Change from baseline plasma β-endorphin values at 1 hour
timeFrame: At 1 hour after the induction of anesthesia and surgery
Secondary outcomes:
measure: Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups
timeFrame: 1 hour
measure: Differences in intraoperative heart rate values (bmp) between the two study groups
timeFrame: 1 hour
measure: Differences in postoperative pain scores scores between the two study groups
timeFrame: Up to 12 postoperative hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon University Hospital
state: Attiki
Study officials:
affiliation: Asklepeion Voulas General Hospital
name: Eirini A Sklika, Consultant
role: PRINCIPAL_INVESTIGATOR
References: