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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFA Group | Active Comparator | patients undergoing FESS under opiod free anesthesia |
|
| TIVA Group | Active Comparator | patients undergoing FESS under total intravenous anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine administration intraoperatively in combination with other drugs used in OFA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain management | Visual Analogue Scale score for pain after FESS | 48 hours |
| Intraoperative bleeding in the surgical field | Surgeon bleeding scale 0-3 for bleeding in the operative field | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Quality of recovery questionnaire for patient satisfaction | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Metaxia Bareka, MD, PhD | Contact | +306947845083 | barekametaxia@hotmail.com | |
| Dimitra Papaspirou, MD | Contact | +306982004382 | dimitra.papaspyrou@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elena Arnaoutoglou, MD, PhD | University of Thessaly | Study Chair |
| Ioannis Chatzioannou, MD, PhD | University of Thessaly | Study Director |
| Dimitra Papaspirou, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Thessaly | Larissa | Thessaly | 41110 | Greece |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Remifentanil | Drug | remifentanil administration intraoperatively in combination with other drugs used in TIVA |
|
| University Hospital of Larissa |
| Principal Investigator |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |