Remifentanil and Fentanyl in Dental Surgery (REFEDS)

NCT02619032 | Completed

• 1 other identifier: ATT968
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

remifentanil; fentanyl; dental surgery

Outcome Measures

Primary Outcomes (5)

• 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

• 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

  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

  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

  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

  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

  1 hour

• Differences in intraoperative heart rate values (bmp) between the two study groups

  1 hour

• Differences in postoperative pain scores scores between the two study groups

  Up to 12 postoperative hours

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.

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.

Drug: Remifentanil; Drug: Fentanyl

Interventions

Remifentanil DRUG

Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.

Also known as: Ultiva

Fentanyl; Remifentanil

Fentanyl DRUG

Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.

Also known as: FNT

Fentanyl; Remifentanil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with cognitive impairment
• of category II according to the American Society of Anesthesiology (ASA) classification
• scheduled for elective dental surgery with short duration

You may not qualify if:

• Patients of more than category II of American Society of Anesthesiology (ASA) classification
• Prolonged duration of surgery (\>1 hour)

Sponsors & Collaborators

• Attikon Hospital: lead
• Asklepieion Voulas General Hospital: collaborator

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Remifentanil; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eirini A Sklika, Consultant

  Asklepeion Voulas General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. of Anaesthesiology

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 2, 2015
• Study Start: October 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

GR (1)