Multimodal Opioid-Free Anesthesia in RIRS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
Sponsormurat sahin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine-Ketamine Opioid-Free Anesthesia

    Drug

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

  • Fentanyl-Based Anesthesia

    Drug

    Conventional opioid-based anesthesia protocol using fentanyl during surgery.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Opioid-Free Anesthesia GroupExperimental treatment 1 intervention
Group B: Opioid-Based Anesthesia GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Within 60 minutes postoperatively

Secondary outcomes

1

Postoperative Opioid Consumption

Total postoperative tramadol consumption during the early postoperative recovery period.

Time frame
Within 60 minutes postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

murat sahin

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Sponsor institution

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