Functional Endoscopic Sinus Surgery
Conditions
Keywords
FESS, Opioid Free Anesthesia, Opioid Consumption
Brief summary
Opioid Free Anesthesia (OFA) - which has been applied mainly in bariatric surgery - has begun to receive more and more attention and to obtain fanatical supporters versus conventional anesthesia. The advantages of this type of anesthesia are mainly achieved by the action and effect of the various drugs that compose it. 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.
Interventions
DRUGDexmedetomidine
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
DRUGRemifentanil
remifentanil administration intraoperatively in combination with other drugs used in TIVA
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 - 75 years old * Elective FESS
Exclusion criteria
1. Patients \< 18 or \>75 years of age 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain management | 48 hours | Visual Analogue Scale score for pain after FESS |
| Intraoperative bleeding in the surgical field | intraoperatively | Surgeon bleeding scale 0-3 for bleeding in the operative field |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 48 hours | Quality of recovery questionnaire for patient satisfaction |
Countries
Greece
Contacts
Primary ContactMetaxia Bareka, MD, PhD
Backup ContactDimitra Papaspirou, MD
Outcome results
None listed