Opioid Free Anesthesia in ENT Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery

Conditions
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Functional Endoscopic Sinus Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 - 75 years old Elective FESS Exclusion Criteria: Patients < 18 or >75 years of age Patients who can't read of speak the Greek language Patients with psychiatric disorders Patients with atrioventricular block in ECG Patients with musculoskeletal disorders Patients with coronary artery disease Patients uncapable of giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OFA Group<br>patients undergoing FESS under opiod free anesthesia | Drug: Dexmedetomidine<br>* dexmedetomidine administration intraoperatively in combination with other drugs used in OFA<br>|
| Active Comparator: TIVA Group<br>patients undergoing FESS under total intravenous anesthesia | Drug: Remifentanil<br>* remifentanil administration intraoperatively in combination with other drugs used in TIVA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Quality of recovery questionnaire for patient satisfaction | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FESS, Opioid Free Anesthesia, Opioid Consumption