Ireland
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Multimodal Opioid-Free Anesthesia in RIRS

NCT07636070 · tracked via the Priya Life Science Turkey tracker
Sponsor
murat sahin
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-09

Condition(s) studied

Kidney StoneRetrograde Intrarenal Surgery (RIRS)Postoperative Pain

Investigational drug(s) / intervention(s)

Dexmedetomidine-Ketamine Opioid-Free AnesthesiaFentanyl-Based Anesthesia

Dexmedetomidine-Ketamine Opioid-Free Anesthesia: Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.

Fentanyl-Based Anesthesia: Conventional opioid-based anesthesia protocol using fentanyl during surgery.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative Pain Intensity — 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.

Trial sites (1)

FacilityCityRegionStatus
Mus State Hospital Muş Muş
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07636070 on ClinicalTrials.gov ↗ ← All trials in Turkey