Postoperative PainREFEDSNCT02619032
Remifentanil and Fentanyl in Dental Surgery (REFEDS)
A study testing Remifentanil and Fentanyl in people with Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Remifentanil and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with cognitive impairment
- of category II according to the American Society of Anesthesiology (ASA) classification
- scheduled for elective dental surgery with short duration
Who cannot join
- Patients of more than category II of American Society of Anesthesiology (ASA) classification
- Prolonged duration of surgery (>1 hour)
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Remifentanil, Fentanyl
- Keywords
- remifentanil, fentanyl, dental surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
FentanylDrug
Also called FNT
Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h. Receives: Drug: Remifentanil; Drug: Fentanyl |
| 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. Receives: Drug: Remifentanil; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasma cortisol values at 1 hour
Plasma cortisol values were measured with an ELISA kit as mg/dl
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 1 hour after the induction of anesthesia and surgery
Secondary outcomes (3)
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
Measured: 1 hour
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
Measured: 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
Measured: Up to 12 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startOct 2005
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepieion Voulas General Hospital
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
- Investigators
- Eirini A Sklika, Consultant, Principal investigator, Asklepeion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619032
- Sponsor's protocol ID
- ATT968
- Acronym
- REFEDS
- Status last verified
- Nov 2015
- First submitted
- 25 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02619032
- Acronym / sponsor ID
- REFEDS / ATT968
- Conditions
- Postoperative Pain
- Keywords
- remifentanil, fentanyl, dental surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- Asklepieion Voulas General Hospital
- Study start
- Oct 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: Remifentanil, Drug: FentanylDrug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h. |
| Fentanyl | Active comparator | Drug: Remifentanil, Drug: FentanylDrug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with cognitive impairment
- of category II according to the American Society of Anesthesiology (ASA) classification
- scheduled for elective dental surgery with short duration
Key exclusion criteria (2 listed)
- Patients of more than category II of American Society of Anesthesiology (ASA) classification
- Prolonged duration of surgery (>1 hour)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: UltivaIntraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention. | Drug | Fentanyl, Remifentanil |
| FentanylAlso: FNTFentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery. | Drug | Fentanyl, Remifentanil |
Primary outcome
Change from baseline plasma cortisol values at 1 hour
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 1 hour after the induction of anesthesia and surgery
β-endorphin was measured with Elisa immunoenzyme assay as ng/ml
3 secondary outcomes
Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups
Time frame: 1 hour
Differences in intraoperative heart rate values (bmp) between the two study groups
Time frame: 1 hour
Differences in postoperative pain scores scores between the two study groups
Time frame: Up to 12 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eirini A Sklika, Consultant principal investigator
Asklepeion Voulas General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and Fentanyl in people with Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline plasma cortisol values at 1 hour (time frame: At 1 hour after the induction of anesthesia and surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.