Opioid Free Anesthesia in ENT Surgery

Functional Endoscopic Sinus Surgery Clinical Trial

Official title:

Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04105946
• Other study ID #: OFA in ENT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University of Thessaly
• Contact: Metaxia Bareka, MD, PhD
• Phone: +306947845083
• Email: barekametaxia[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Endoscopic Sinus Surgery

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
• Remifentanil
remifentanil administration intraoperatively in combination with other drugs used in TIVA

Locations

Country	Name	City	State
Greece	Univeristy of Thessaly	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain management	Visual Analogue Scale score for pain after FESS	48 hours
Primary	Intraoperative bleeding in the surgical field	Surgeon bleeding scale 0-3 for bleeding in the operative field	intraoperatively
Secondary	Patient Satisfaction	Quality of recovery questionnaire for patient satisfaction	48 hours