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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Isabel Marcolino, Dr. med.
- Telefonnummer: +41 44 733 2891
- E-mail: isabel.marcolino@spital-limmattal.ch
Undersøgelse Kontakt Backup
- Navn: Cornelia Stress, MSc
- Telefonnummer: +41 44 736 85 76
- E-mail: Cornelia.stress@spital-limmattal.ch
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain intensity Measured by the numeric rating scale (NRS) in the Post-anesthesia care unit (PACU)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety endpoints
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-01332
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