Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia (OFANOL)
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia for Bariatric Surgery: A Prospective Randomized Controlled Trial
Participants will be randomized to one of two predefined NOL®-guided analgesia strategies during bariatric surgery performed under OFA. In both groups the NOL® index will be continuously monitored intraoperatively and dexmedetomidine will be administered according to the assigned study algorithm based on the NOL® index using lean body weight (LBW) for dosing.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The study aims to evaluate whether different intraoperative target ranges of the NOL® index during bariatric surgery performed under OFA are associated with differences in postoperative analgesic consumption and postoperative pain control without significant differences in intraoperative hemodynamics. Based on the physiological mechanisms outlined above, we hypothesize that during OFA with alpha-2 agonists such as dexmedetomidine, intensified NOL® target ranges (potentially 0-10) may be appropriate compared to the established range of 10-25 for opioid based TIVA. If this hypothesis is confirmed, clinical implications would include the need to establish OFA-specific NOL® target ranges to avoid under-treatment of nociception when applying TIVA-derived thresholds to OFA patients. Conversely, using inappropriately high NOL® targets derived from opioid-based anesthesia might lead to inadequate pain control and to excessive administration of analgesics postoperatively.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Isabel Marcolino, Dr. med.
- 전화번호: +41 44 733 2891
- 이메일: isabel.marcolino@spital-limmattal.ch
연구 연락처 백업
- 이름: Cornelia Stress, MSc
- 전화번호: +41 44 736 85 76
- 이메일: Cornelia.stress@spital-limmattal.ch
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Signed informed consent
- Age ≥ 18 years
- bariatric surgery (sleeve/bypass/Re-Do)
Exclusion Criteria:
- Patients with contraindications for dexmedetomidine or lidocaine
- Lack of ability to follow the study procedure, e.g. due to severe language barriers, mental disorders, dementia - Patients requiring preoperative or postoperative treatment in the intensive care unit (ICU) (excluding Obstructive sleep apnea syndrome (OSAS))
- Patients with conditions precluding the use of the NOL® sensor, such as neuromuscular deficits affecting hand function
- BMI <25 kg/m2
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Intensive NOL®-guided strategy
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.3 ug/kg LBW/h. |
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.3 ug/kg LBW/h. |
|
실험적: Conservative NOL®-guided strategy
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.1 ug/kg LBW/h. |
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.1 ug/kg LBW/h. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain intensity Measured by the numeric rating scale (NRS) in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
To evaluate whether an intensive NOL®-guided analgesia strategy reduces postoperative pain intensity in the post-anesthesia care unit (PACU) compared to a conservative NOL®-guided analgesia strategy in patients undergoing bariatric surgery under OFA. |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
Postoperative pain intensity Measured by the Behavioral Pain Scale (BPS) in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
To evaluate whether an intensive NOL®-guided analgesia strategy reduces postoperative pain intensity in the post-anesthesia care unit (PACU) compared to a conservative NOL®-guided analgesia strategy in patients undergoing bariatric surgery under OFA. |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference between postoperative pain intensity measurement using the Behavioral Pain Scale (BPS) (outcome 1) and numeric rating scale (NRS) (outcome 2) in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Difference between the outcome 1 and outcome 2 |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
Total opioid consumption in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Morphin (mg), Oxynorm (mg), Oxycodon/Naloxon (mg) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Paracetamol (mg), Metamizol (mg), Ketamin (mg) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Lidocain-P (mg/kgLBW/h) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Ketamin-Perfusor (mg/h) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Incidence of Postoperative nausea and vomiting (PONV)
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
The proportion of patients who experience at least one episode of postoperative nausea, retching, or vomiting, or who require the administration of any antiemetic rescue medication (such as Ondansetron, Metoclopramide, Domperidone, or Itinerol). |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Richmond Agitation-Sedation Scale (RASS) scores during Post-anesthesia care unit (PACU) stay
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
|
- Quality of Recovery-15 (QoR-15) score on postoperative day 1
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety endpoints
기간: At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
- measures of intraoperative hemodynamic stability, including the incidence of hypotension, bradycardia, hypertension, tachycardia, and vasoactive medication use - occurrence of AEs and SAEs during the study period |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-01332
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