Skip to main content
Clinical Trials/NCT04105946
NCT04105946
Unknown
Not Applicable

Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery

University of Thessaly1 site in 1 country200 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Functional Endoscopic Sinus Surgery
Sponsor
University of Thessaly
Enrollment
200
Locations
1
Primary Endpoint
Pain management
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Arnaoutoglou

Professor of Anesthesiology

University of Thessaly

Eligibility Criteria

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

Arms & Interventions

OFA Group

patients undergoing FESS under opiod free anesthesia

Intervention: Dexmedetomidine

TIVA Group

patients undergoing FESS under total intravenous anesthesia

Intervention: Remifentanil

Outcomes

Primary Outcomes

Pain management

Time Frame: 48 hours

Visual Analogue Scale score for pain after FESS

Intraoperative bleeding in the surgical field

Time Frame: intraoperatively

Surgeon bleeding scale 0-3 for bleeding in the operative field

Secondary Outcomes

  • Patient Satisfaction(48 hours)

Study Sites (1)

Loading locations...

Similar Trials