Opioid Free Anesthesia in ENT Surgery

Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Endoscopic Sinus Surgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitra Papaspirou, MD; Phone Number: +306982004382; Email: dimitra.papaspyrou@hotmail.com

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Univeristy of Thessaly
      • Contact: Dimitra Papaspirou; Phone Number: +306982004382; Email: dimitra.papaspyrou@hotmail.com
      • Sub-Investigator: Jiannis Hajiioannou, MD, PhD
      • Sub-Investigator: Athanasios Chalkias, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: OFA Group; patients undergoing FESS under opiod free anesthesia	Drug: Dexmedetomidine; dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
ACTIVE_COMPARATOR: TIVA Group; patients undergoing FESS under total intravenous anesthesia	Drug: Remifentanil; remifentanil administration intraoperatively in combination with other drugs used in TIVA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Director: Ioannis Chatzioannou, MD, PhD, University of Thessaly; Principal Investigator: Dimitra Papaspirou, MD, University Hospital Of Larissa

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Opioid Consumption; FESS; Opioid Free Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: OFA in ENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No