Opioid-Free Anesthesia in FESS: A Prospective ERAS Study

NCT07812389 | Recruiting

• 1 other identifier: E2-26-16061
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Information for Patients and Families What is this study about? When patients undergo functional endoscopic sinus surgery (FESS), strong pain relievers called opioids are traditionally used during anesthesia. While effective, opioids can sometimes cause unwanted side effects such as nausea, vomiting, dizziness, or prolonged recovery times. This study investigates an "Opioid-Free Anesthesia" (OFA) approach combined with Enhanced Recovery After Surgery (ERAS) protocols. ERAS is a modern, science-based care pathway designed to help patients recover faster and more comfortably after surgery.
2. 2.Technical Summary for Health Care Providers Official Study Title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study Study Rationale and Objective: Traditional opioid-based anesthesia is often associated with opioid-induced side effects (OIAEs) such as postoperative nausea and vomiting (PONV), respiratory depression, and delayed discharge. This prospective observational study aims to evaluate the clinical impact of Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway for patients undergoing elective Functional Endoscopic Sinus Surgery (FESS). The primary focus is to assess whether an OFA-ERAS strategy optimizes perioperative outcomes, stabilizes intraoperative hemodynamics, and minimizes recovery times compared to historical opioid-based standards.

Conditions

Chronic Sinusitis; Postoperative Pain; Postoperative Nausea and Vomiting (PONV); Surgical Field Visibility; Enhanced Recovery After Surgery (ERAS) Protocol; Blood Loss, Surgical; Opioid-free Anesthesia; Functional Endoscopic Sinus Surgery (FESS)

Keywords

Opioid-Free Anesthesia; Functional Endoscopic Sinus Surgery; Postoperative Nausea and Vomiting; Enhanced Recovery After Surgery; Surgical Field Visibility; Blood Loss, Surgical; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Quality of the Surgical Field Assessed by Fromme-Boezaart Scoring System

  Comparison of the surgical field quality between the Opioid-Free Anesthesia (OFA) group and the traditional opioid group. The quality of the surgical field visibility will be evaluated by the operating surgeon using a validated visual scoring system, such as the Fromme-Boezaart Surgical Field Scoring System (ranging from 0 = no bleeding to 5 = severe bleeding, where lower scores indicate better surgical conditions).

  Perioperative/Periprocedural

Secondary Outcomes (5)

• Surgeon Satisfaction Score Assessed by a 5-Point Likert Scale

  Immediately after the completion of the surgical procedure.

• Heart Rate (HR)

  Perioperative/Periprocedural

• Postoperative Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

  Postoperative Day 7

• Mean Arterial Pressure (MAP)

  Perioperative/Periprocedural

• Severity of Postoperative Nausea and Vomiting (PONV)

  Postoperative 24 hours

Study Arms (2)

OFA Group

Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive dexmedetomidine-based Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway. No intraoperative opioids will be administered to this cohort.

Drug: Dexmedetomidine

O Group (Opioid Group)

Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive traditional remifentanil-based opioid anesthesia embedded within the same Enhanced Recovery After Surgery (ERAS) pathway.

Drug: Remifentanil

Interventions

Dexmedetomidine DRUG

Patients in the Opioid-Free Anesthesia (OFA) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) with a propofol infusion. Intraoperative analgesia and hemodynamic control are managed using a dexmedetomidine infusion combined with non-opioid multimodal analgesics, embedded within an institutional ERAS pathway. Brain function monitoring (Masimo SedLine®) is used to guide anesthesia depth. No intraoperative systemic opioids are administered.

OFA Group

Remifentanil DRUG

Patients in the Opioid (O) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) using a propofol infusion. Intraoperative analgesia is provided through a traditional remifentanil-based continuous intravenous infusion protocol, managed within the same institutional ERAS pathway.

O Group (Opioid Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients aged 18 to 65 years who are scheduled to undergo elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis at Ankara Bilkent City Hospital, a tertiary care referral and teaching hospital in Ankara, Turkey. The study population comprises consecutive eligible patients whose perioperative anesthetic and surgical management is monitored following institutional Enhanced Recovery After Surgery (ERAS) pathways.

You may qualify if:

• Patients aged between 18 and 65 years.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Patients scheduled for elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis.
• Patients whose perioperative care is managed strictly according to institutional Enhanced Recovery After Surgery (ERAS) principles.

You may not qualify if:

• Known cardiac conduction abnormalities or arrhythmias.
• History of chronic opioid use or opioid dependency.
• Current use of beta-blockers or antiarrhythmic medications.
• Severe hepatic or renal impairment.
• Obesity defined as a Body Mass Index (BMI) greater than 35 kg/m².
• Current use of GLP-1 receptor agonists.
• Documented coagulopathy or bleeding disorders.
• History of prior revision Functional Endoscopic Sinus Surgery (FESS) procedures.
• History of delayed gastric emptying or high risk of pulmonary aspiration.

Sponsors & Collaborators

• Filiz Kaya: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Moeen SM, Mandour AM, Soliman OM, Osman MM. Effect of lidocaine infusion on intraoperative bleeding during functional endoscopic sinus surgery: a randomized controlled trial. Minerva Anestesiol. 2022 Nov;88(11):901-909. doi: 10.23736/S0375-9393.22.16475-8. Epub 2022 Jun 29.

  PMID: 35766954 BACKGROUND

• Wu Y, Fu Y, He Y, Gong X, Han Z, Fan H, Zhu T, Li H. The application of enhanced recovery after surgery (ERAS) in chronic rhinosinusitis patients undergoing endoscopic sinus surgery: A systematic review and meta-analysis. PLoS One. 2023 Sep 21;18(9):e0291835. doi: 10.1371/journal.pone.0291835. eCollection 2023.

  PMID: 37733792 BACKGROUND

• Shen Y, Wu Y, Tang Q, Wang Y, Ma W, Wang J. Efficacy of opioid-free anesthesia in reducing postoperative nausea and vomiting following gynecological laparoscopic surgery: a randomized controlled trial. Front Med (Lausanne). 2025 Jul 17;12:1606383. doi: 10.3389/fmed.2025.1606383. eCollection 2025.

  PMID: 40747089 BACKGROUND

• Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.

  PMID: 33478255 BACKGROUND

• Karabayirli S, Ugur KS, Demircioglu RI, Muslu B, Usta B, Sert H, Ark N. Surgical conditions during FESS; comparison of dexmedetomidine and remifentanil. Eur Arch Otorhinolaryngol. 2017 Jan;274(1):239-245. doi: 10.1007/s00405-016-4220-1. Epub 2016 Jul 28.

  PMID: 27470115 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Blood Loss, Surgical

Interventions

Dexmedetomidine; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Hemorrhage; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Filiz Kaya, M.D.

  Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Kaya, M.D

CONTACT

+903125526000; fbulut5@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 10, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)