Remifentanil and Fentanyl in Dental Surgery (REFEDS) (REFEDS)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Remifentanil
Fentanyl
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring remifentanil, fentanyl, dental surgery
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)
Sites / Locations
- 2nd Department of Anesthesiology, Attikon University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Remifentanil
Fentanyl
Arm Description
Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.
Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.
Outcomes
Primary Outcome Measures
Change from baseline plasma cortisol values at 1 hour
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
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
Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml
Change from baseline plasma melatonin values at 1 hour
Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml
Change from baseline plasma β-endorphin values at 1 hour
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
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
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
Pain was assessed using the Wong-Baker faces pain rating scale (0-6) at 12 postoperative hours
Full Information
NCT ID
NCT02619032
First Posted
November 25, 2015
Last Updated
November 30, 2015
Sponsor
Attikon Hospital
Collaborators
Asklepieion Voulas General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02619032
Brief Title
Remifentanil and Fentanyl in Dental Surgery (REFEDS)
Acronym
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
Collaborators
Asklepieion Voulas General Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
remifentanil, fentanyl, dental surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
FNT
Intervention Description
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Primary Outcome Measure Information:
Title
Change from baseline plasma cortisol values at 1 hour
Description
Plasma cortisol values were measured with an ELISA kit as mg/dl
Time Frame
At 1 hour after the induction of anesthesia and surgery
Title
Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour
Description
Tumor necrosis factor-α (TNF-α) measurement was performed with Elisa immunoenzyme assay as pg/ml
Time Frame
At 1 hour after the induction of anesthesia and surgery
Title
Change from baseline plasma substance-P values at 1 hour
Description
Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml
Time Frame
At 1 hour after the induction of anesthesia and surgery
Title
Change from baseline plasma melatonin values at 1 hour
Description
Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml
Time Frame
At 1 hour after the induction of anesthesia and surgery
Title
Change from baseline plasma β-endorphin values at 1 hour
Description
β-endorphin was measured with Elisa immunoenzyme assay as ng/ml
Time Frame
At 1 hour after the induction of anesthesia and surgery
Secondary Outcome Measure Information:
Title
Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups
Description
Measurements before the induction of anesthesia (baseline values) and at and 60 min (1 hour) after the induction of anesthesia
Time Frame
1 hour
Title
Differences in intraoperative heart rate values (bmp) between the two study groups
Description
Measurements before the induction of anesthesia (baseline values) and at 60 min (1 hour) after the induction of anesthesia
Time Frame
1 hour
Title
Differences in postoperative pain scores scores between the two study groups
Description
Pain was assessed using the Wong-Baker faces pain rating scale (0-6) at 12 postoperative hours
Time Frame
Up to 12 postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eirini A Sklika, Consultant
Organizational Affiliation
Asklepeion Voulas General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon University Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
12. IPD Sharing Statement
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Remifentanil and Fentanyl in Dental Surgery (REFEDS)
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