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Opioid-Free anesthesia in functional endoscopic sinus surgery: effects on perioperative outcomes - a prospective observational ERAS study

NCT ID NCT07812389

NEW Sponsor: Filiz Kaya Source: ClinicalTrials.gov ↗

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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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. Why is this study important? The goal of this study is to see if skipping opioids during sinus surgery-and using alternative pain-management techniques instead-leads to better perioperative outcomes. We want to find out if patients experience less pain, fewer side effects (like nausea), and a quicker, safer return to their daily routines. What will happen if you participate? If you fit the criteria and agree to join, your surgical journey will follow the standard ERAS protocol, but your anesthesia will be managed without conventional opioid medications. Researchers will closely monitor your comfort, pain levels, and recovery speed before, during, and after your sinus surgery. 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. Study Design: Prospective, Observational Study. Estimated Enrollment: 104 patients. Setting: Perioperative tracking following strict institutional ERAS principles.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Both female and male patients are eligible for inclusion. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Pain, Postoperative Postoperative Nausea and Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood loss, surgical Chronic sinusitis Enhanced recovery after surgery (ERAS) protocol Functional endoscopic sinus surgery (FESS) Opioid-free anesthesia Postoperative nausea and vomiting (PONV) Postoperative pain Surgical field visibility

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ankara Bilkent City Hospital

    RECRUITING

    Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

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