Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06800, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ezgi Erkılıç, Prof.
CONTACT
FİLİZ KAYA, M.D.
CONTACT
NCT Number: NCT07812389
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Ankara, ÇANKAYA, 06800, Turkey (Türkiye)
Location status: Recruiting
Ezgi Erkılıç, Prof.
CONTACT
FİLİZ KAYA, M.D.
CONTACT
This prospective observational study is designed to evaluate perioperative clinical outcomes in patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) under routine clinical care. In accordance with the observational nature of the study, the investigators do not assign or control the anesthetic techniques, drug dosages, or clinical pathways. All perioperative interventions, including the choice between an opioid-free anesthesia (OFA) approach or traditional opioid-based anesthesia, are determined solely by the attending anesthesiologists based on standard institutional protocols and clinical judgment.
Data collection will encompass the entire perioperative period, spanning from the pre-anesthesia assessment until the standard post-operative follow-up intervals.
The clinical tracking workflow consists of the following phases:
Statistical analyses will be performed to evaluate and compare the collected perioperative datasets between patients who received dexmedetomidine-based opioid-free anesthesia and those who received traditional opioid-based regimens under the institutional Enhanced Recovery After Surgery (ERAS) framework. No additional clinical interventions, blood samplings, or changes to standard patient care pathways are introduced due to study participation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Perioperative/Periprocedural
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).
Time frame: Immediately after the completion of the surgical procedure.
Assessment of the operating surgeon's overall satisfaction regarding the surgical conditions, field visibility, and patient immobility during the procedure. It will be evaluated using a 5-point Likert scale (ranging from 1 = Very Dissatisfied to 5 = Very Satisfied, where higher scores indicate a higher level of surgeon satisfaction)
Time frame: Perioperative/Periprocedural
Comparison of intraoperative heart rate (measured in beats per minute) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Time frame: Postoperative Day 7
Evaluation and comparison of the patient's subjective sleep quality during the first postoperative week between the two study cohorts. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which ranges from a minimum score of 0 to a maximum score of 21. A higher global score indicates worse sleep quality.
Time frame: Perioperative/Periprocedural
Comparison of intraoperative mean arterial pressure (measured in mmHg) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Time frame: Postoperative 24 hours
Evaluation and comparison of the severity of postoperative nausea and vomiting between the two study cohorts. The severity of PONV will be assessed using a validated Visual Analog Scale (VAS) scoring system adapted from the literature: 0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea/vomiting. Lower scores indicate a lower burden of opioid-induced emetic side effects.
Contact information is provided by the study sponsor or research team.
Filiz Kaya
Other
Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study
Acronym: OFA-FESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06824649
Chronic Sinusitis, Infections
Portland, Oregon, United States
View Trial DetailsNCT07151313
Acute Sinusitis, Bronchial Diseases
Cairo, Egypt
View Trial DetailsNCT04678856
Chronic Rhinosinusitis Without Nasal Polyps, Chronic Sinusitis
Roseville, California, United States
View Trial DetailsNCT04187976
Asthma, Bronchial Diseases
Lille, France
View Trial Details