Kidney StoneNCT07636070
Multimodal Opioid-Free Anesthesia in RIRS
A study testing Dexmedetomidine-Ketamine Opioid-Free Anesthesia and Fentanyl-Based Anesthesia in people with Kidney Stone and Retrograde Intrarenal Surgery (RIRS), run by murat sahin at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Stone, Retrograde Intrarenal Surgery (RIRS), Postoperative Pain
- What is being tested?
- Dexmedetomidine-Ketamine Opioid-Free Anesthesia and Fentanyl-Based Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 10 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Omer Faruk Bilin contact
Turkey (Türkiye)1 site
Mus State Hospital
Muş, Muş, 49100
MURAT SAHIN, +905070666680, mrtshn52@gmail.com
About this study
Official title: 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?
Read more
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.
Read the detailed description
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.
- Being tested
- Dexmedetomidine-Ketamine Opioid-Free Anesthesia, Fentanyl-Based Anesthesia
- Keywords
- Opioid-Free Anesthesia, Dexmedetomidine, Ketamine, Postoperative Analgesia, Multimodal Analgesia, Laryngeal Mask Airway
- Medical subject headings
- Kidney Calculi, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine-Ketamine Opioid-Free AnesthesiaDrug
Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.
Fentanyl-Based AnesthesiaDrug
Conventional opioid-based anesthesia protocol using fentanyl during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia Group | Experimental | 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). Receives: Drug: Dexmedetomidine-Ketamine Opioid-Free Anesthesia |
| Opioid-Based Anesthesia Group | Active comparator | Participants receive conventional fentanyl-based anesthesia during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA). Receives: Drug: Fentanyl-Based Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at PACU arrival, 30 minutes, and 60 minutes postoperatively.
Measured: Within 60 minutes postoperatively
Secondary outcomes (1)
Postoperative Opioid Consumption
Total postoperative tramadol consumption during the early postoperative recovery period.
Measured: Within 60 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an opioid-free anesthesia group or a conventional opioid-based anesthesia group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- murat sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, murat sahin, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636070
- Sponsor's protocol ID
- 1249
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No