Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-10-31
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Functional Endoscopic Sinus Surgery is performed in cases where sinusitis or its complications are difficult to treat with medication. With special cameras and endoscopes, the narrow anatomical regions of the sinus can be depicted and precisely surgically approached. Usually surgery is conducted under general anesthesia. According to the literature, total intravenous anesthesia should be used for sinus surgery to achieve blood pressure control as well as controlled hypotension to prevent intraoperative bleeding. Most of the studies agree that the best type of anesthesia for this type of surgery is total intravenous anesthesia. When it comes to Opioid Free Anesthesia in FESS, there are not many studies, except of some studies that don't use solely Opioid Free Anesthesia but some of the drugs that consist it.
Patients scheduled for elective Functional Endoscopic Sinus Surgery will be randomised in two groups. One receiving OFA and one receiving TIVA.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimal Remifentanil Concentration and Thyroidectomy
NCT03218124
Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia
NCT02093143
Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
NCT03120234
EC95 of Remifentanil for Preventing Cough
NCT02973724
Opioid Free Anesthesia on the Quality of Early Recovery
NCT05577962
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OFA Group
patients undergoing FESS under opiod free anesthesia
Dexmedetomidine
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
TIVA Group
patients undergoing FESS under total intravenous anesthesia
Remifentanil
remifentanil administration intraoperatively in combination with other drugs used in TIVA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
Remifentanil
remifentanil administration intraoperatively in combination with other drugs used in TIVA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective FESS
Exclusion Criteria
2. Patients who can't read of speak the Greek language
3. Patients with psychiatric disorders
4. Patients with atrioventricular block in ECG
5. Patients with musculoskeletal disorders
6. Patients with coronary artery disease
7. Patients uncapable of giving informed consent
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Thessaly
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elena Arnaoutoglou
Professor of Anesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elena Arnaoutoglou, MD, PhD
Role: STUDY_CHAIR
University of Thessaly
Ioannis Chatzioannou, MD, PhD
Role: STUDY_DIRECTOR
University of Thessaly
Dimitra Papaspirou, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Larissa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univeristy of Thessaly
Larissa, Thessaly, Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OFA in ENT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.