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Multimodal Opioid-Free Anesthesia in RIRS

4. juni 2026 opdateret af: murat sahin

Multimodal Opioid-Free Anesthesia in RIRS: A Comparison of Dexmedetomidine-Ketamine Combination Versus Conventional Opioid-Based Protocols

The goal of this clinical trial is to evaluate whether a dexmedetomidine-ketamine based opioid-free anesthesia (OFA) protocol can provide effective analgesia compared to conventional fentanyl-based anesthesia in adult patients undergoing elective retrograde intrarenal surgery (RIRS). The main questions it aims to answer are:

Does opioid-free anesthesia reduce postoperative opioid consumption compared to fentanyl-based anesthesia? Does opioid-free anesthesia result in lower postoperative pain scores?

Researchers will compare the dexmedetomidine-ketamine group to the fentanyl-based anesthesia group to see if opioid-free anesthesia reduces opioid requirements and improves recovery quality.

Participants will receive either a dexmedetomidine-ketamine based OFA protocol or conventional fentanyl-based anesthesia during surgery and will be monitored for pain, opioid consumption, and recovery outcomes postoperatively.

Studieoversigt

Detaljeret beskrivelse

Opioids have traditionally been the cornerstone of perioperative analgesia; however, opioid-related adverse effects such as respiratory depression, postoperative nausea and vomiting (PONV), opioid-induced hyperalgesia, sedation, and delayed recovery may negatively affect postoperative outcomes. Opioid-free anesthesia (OFA) is a multimodal anesthetic approach that aims to provide adequate analgesia while minimizing or eliminating perioperative opioid exposure.

Dexmedetomidine and ketamine are commonly used components of OFA protocols. Dexmedetomidine provides sedation and analgesia through selective alpha-2 adrenergic receptor agonism without significant respiratory depression, whereas ketamine reduces central sensitization and opioid-induced hyperalgesia through NMDA receptor antagonism. Their combined use may provide synergistic analgesic and hemodynamic effects.

Retrograde intrarenal surgery (RIRS) is a minimally invasive endourological procedure commonly performed for renal stone disease. Rapid postoperative recovery and early discharge are important goals in this patient population. The use of laryngeal mask airway (LMA) may further facilitate smoother airway management and recovery.

This prospective, randomized, single-center, assessor-blinded clinical trial will compare a dexmedetomidine-ketamine based OFA protocol with conventional fentanyl-based anesthesia in adult patients undergoing elective RIRS under LMA. Eligible participants will be randomized in a 1:1 ratio to either the opioid-free anesthesia group or the opioid-based anesthesia group.

The primary outcomes are postoperative pain scores assessed using the Numeric Rating Scale (NRS) and postoperative opioid consumption during the early recovery period. Secondary outcomes include recovery characteristics, intraoperative hemodynamic parameters, quality of LMA removal, intraoperative patient movement, postoperative nausea and vomiting, surgeon satisfaction, and perioperative adverse events.

The investigators hypothesize that the OFA protocol may reduce postoperative opioid requirements and improve recovery quality while maintaining adequate perioperative analgesia and hemodynamic stability.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Omer Faruk Bilin
  • Telefonnummer: +905383975966

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

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  • Ældre voksen

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Beskrivelse

Inclusion Criteria:

Aged 18 to 65 years ASA physical status I or II ASA III patients with controlled and stable systemic disease (e.g., well-controlled hypertension or type 2 diabetes without end-organ damage) Scheduled for elective retrograde intrarenal surgery (RIRS) under laryngeal mask airway (LMA) Ability to provide written informed consent

Exclusion Criteria:

BMI greater than 40 kg/m² Chronic opioid use Severe cardiovascular disease (uncontrolled arrhythmia, unstable angina, or ejection fraction below 40%) Significant respiratory disease (FEV1 below 60% predicted or oxygen-dependent COPD) Neuropsychiatric disorders Pregnancy Known allergy to any study drug Anticipated difficult airway (Mallampati III-IV, mouth opening less than 3 cm, or thyromental distance less than 6 cm) Requirement for conversion from LMA to endotracheal intubation Emergency cases Withdrawal of informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Opioid-Free Anesthesia Group
Participants receive an opioid-free anesthesia protocol consisting of dexmedetomidine infusion and ketamine administration during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA).
Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.
Aktiv komparator: Opioid-Based Anesthesia Group
Participants receive conventional fentanyl-based anesthesia during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA).
Conventional opioid-based anesthesia protocol using fentanyl during surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Intensity
Tidsramme: Within 60 minutes postoperatively
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at PACU arrival, 30 minutes, and 60 minutes postoperatively.
Within 60 minutes postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Opioid Consumption
Tidsramme: Within 60 minutes postoperatively
Total postoperative tramadol consumption during the early postoperative recovery period.
Within 60 minutes postoperatively

Samarbejdspartnere og efterforskere

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Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

10. august 2026

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Dexmedetomidine-Ketamine Opioid-Free Anesthesia

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