- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636070
Multimodal Opioid-Free Anesthesia in RIRS
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?
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: MURAT SAHIN
- 전화번호: +905070666680
- 이메일: mrtshn52@gmail.com
연구 연락처 백업
- 이름: Omer Faruk Bilin
- 전화번호: +905383975966
연구 장소
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Muş
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Muş, Muş, 터키 (Türkiye), 49100
- Mus State Hospital
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연락하다:
- MURAT SAHIN
- 전화번호: +905070666680
- 이메일: mrtshn52@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Opioid-Free Anesthesia Group
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).
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Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.
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활성 비교기: Opioid-Based Anesthesia Group
Participants receive conventional fentanyl-based anesthesia during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA).
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Conventional opioid-based anesthesia protocol using fentanyl during surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Intensity
기간: Within 60 minutes postoperatively
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Postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at PACU arrival, 30 minutes, and 60 minutes postoperatively.
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Within 60 minutes postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Opioid Consumption
기간: Within 60 minutes postoperatively
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Total postoperative tramadol consumption during the early postoperative recovery period.
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Within 60 minutes postoperatively
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1249
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Dexmedetomidine-Ketamine Opioid-Free Anesthesia에 대한 임상 시험
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Sohag University모병