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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
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

+905383975966

Turkey (Türkiye)1 site
  • Mus State Hospital

    Muş, Muş, 49100

    MURAT SAHIN, +905070666680, mrtshn52@gmail.com

Other trials in Turkey (Türkiye)

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 groups in NCT07636070
Study groupRoleWhat they receive
Opioid-Free Anesthesia GroupExperimentalParticipants 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 GroupActive comparatorParticipants 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.

  1. 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)
  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.

  1. First posted9 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion10 Aug 2026 (estimated)

Resources

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)
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

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