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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Isabel Marcolino, Dr. med.
- Numer telefonu: +41 44 733 2891
- E-mail: isabel.marcolino@spital-limmattal.ch
Kopia zapasowa kontaktu do badania
- Nazwa: Cornelia Stress, MSc
- Numer telefonu: +41 44 736 85 76
- E-mail: Cornelia.stress@spital-limmattal.ch
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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. |
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative pain intensity Measured by the numeric rating scale (NRS) in the Post-anesthesia care unit (PACU)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Safety endpoints
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026-01332
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .