Multimodal Opioid-Free Anesthesia in RIRS

NCT07636070 | Not Yet Recruiting

• 1 other identifier: 1249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone; Retrograde Intrarenal Surgery (RIRS); Postoperative Pain

Keywords

Opioid-Free Anesthesia; Dexmedetomidine; Ketamine; Postoperative Analgesia; Multimodal Analgesia; Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (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.

  Within 60 minutes postoperatively

Secondary Outcomes (1)

• Postoperative Opioid Consumption

  Within 60 minutes postoperatively

Study Arms (2)

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).

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).

Drug: Fentanyl-Based Anesthesia

Interventions

Fentanyl-Based Anesthesia DRUG

Conventional opioid-based anesthesia protocol using fentanyl during surgery.

Opioid-Based Anesthesia Group

Dexmedetomidine-Ketamine Opioid-Free Anesthesia DRUG

Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.

Opioid-Free Anesthesia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• murat sahin: lead

Study Sites (1)

Mus State Hospital

Muş, Muş, 49100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

murat sahin

CONTACT

+905070666680; mrtshn52@gmail.com

Omer Faruk Bilin

CONTACT

+905383975966

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcome assessors were blinded to group allocation. The anesthesiologist administering anesthesia was not blinded because of the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an opioid-free anesthesia group or a conventional opioid-based anesthesia group.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)