Remifentanil and Fentanyl in Dental Surgery (REFEDS)

Postoperative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619032
• Other study ID #: ATT968
• Status: Completed
• Phase: N/A
• First received: November 25, 2015
• Last updated: November 30, 2015
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical 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). Secondary aims were to investigate comparatively their effect on patients intraoperative hemodynamic response and postoperative analgesia.

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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Remifentanil
Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
• Fentanyl
Fentanyl 50 µg iv bolus at the induction of anesthesia and before the start of surgery.

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon University Hospital	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	Asklepieion Voulas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

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